Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT03257995
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2017-06-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510790', 'term': 'indacaterol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'until 30 days after the last Investigational Product (IP) administration', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 14, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 7, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 9, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trough FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4173', 'spread': '0.78214', 'groupId': 'OG000'}, {'value': '2.3774', 'spread': '0.77679', 'groupId': 'OG001'}, {'value': '2.2191', 'spread': '0.72350', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1861', 'ciLowerLimit': '0.1293', 'ciUpperLimit': '0.2429', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1463', 'ciLowerLimit': '0.0898', 'ciUpperLimit': '0.2029', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0398', 'ciLowerLimit': '-0.0942', 'ciUpperLimit': '0.0147', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics AUC 0-24hours at Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '2300', 'spread': '732', 'groupId': 'OG000'}, {'value': '2050', 'spread': '636', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'The Maximum Concentration (Cmax) at Steady State (ss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000', 'lowerLimit': '126', 'upperLimit': '443'}, {'value': '224', 'groupId': 'OG001', 'lowerLimit': '84.9', 'upperLimit': '426'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Time of Maximal Plasma Concentration (Tmax) at Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.183', 'upperLimit': '0.850'}, {'value': '0.467', 'groupId': 'OG001', 'lowerLimit': '0.183', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '126'}, {'value': '52.3', 'groupId': 'OG001', 'lowerLimit': '9.03', 'upperLimit': '106'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.'}, {'type': 'SECONDARY', 'title': 'Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate / Indacaterol Acetate', 'description': 'Relative bioavailability of indacaterol acetate compared to indacaterol maleate (Frel) AUC0-24h,ss'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'Relative bioavailability of indacaterol acetate compared to indacaterol maleate (Frel) Cmax,ss'}], 'classes': [{'categories': [{'measurements': [{'value': '0.912', 'spread': '0.201', 'groupId': 'OG000'}, {'value': '0.910', 'spread': '0.242', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': 'Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data. Only summary statistics for relative bioavailability was provided.'}, {'type': 'SECONDARY', 'title': 'Time to Peak FEV1 on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-0.83', 'upperLimit': '0.33'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '0.51'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-0.50', 'upperLimit': '0.73'}]}]}], 'analyses': [{'pValue': '0.823', 'groupIds': ['OG000'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.33', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.801', 'groupIds': ['OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.51', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.984', 'groupIds': ['OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.73', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo', 'unitOfMeasure': 'h', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4795', 'groupId': 'OG000', 'lowerLimit': '2.2575', 'upperLimit': '2.7014'}, {'value': '2.4813', 'groupId': 'OG001', 'lowerLimit': '2.2595', 'upperLimit': '2.7031'}, {'value': '2.2617', 'groupId': 'OG002', 'lowerLimit': '2.0398', 'upperLimit': '2.4837'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5005', 'groupId': 'OG000', 'lowerLimit': '2.2786', 'upperLimit': '2.7224'}, {'value': '2.4965', 'groupId': 'OG001', 'lowerLimit': '2.2746', 'upperLimit': '2.7184'}, {'value': '2.2282', 'groupId': 'OG002', 'lowerLimit': '2.0062', 'upperLimit': '2.4501'}]}]}, {'title': '30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5204', 'groupId': 'OG000', 'lowerLimit': '2.2985', 'upperLimit': '2.7424'}, {'value': '2.5047', 'groupId': 'OG001', 'lowerLimit': '2.2829', 'upperLimit': '2.7265'}, {'value': '2.2475', 'groupId': 'OG002', 'lowerLimit': '2.0255', 'upperLimit': '2.4694'}]}]}, {'title': '1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5279', 'groupId': 'OG000', 'lowerLimit': '2.3060', 'upperLimit': '2.7498'}, {'value': '2.5018', 'groupId': 'OG001', 'lowerLimit': '2.2800', 'upperLimit': '2.7236'}, {'value': '2.2670', 'groupId': 'OG002', 'lowerLimit': '2.0451', 'upperLimit': '2.4889'}]}]}, {'title': '2 hour', 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'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.6', 'ciLowerLimit': '5.5', 'ciUpperLimit': '9.7', 'groupDescription': 'at 12 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '4.8', 'ciUpperLimit': '9.1', 'groupDescription': 'at 23 hours 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '4.2', 'ciUpperLimit': '8.6', 'groupDescription': 'at 23 hours 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '5.0', 'ciUpperLimit': '9.2', 'groupDescription': 'at 5 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '6.2', 'ciUpperLimit': '10.4', 'groupDescription': 'at 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '6.0', 'ciUpperLimit': '10.2', 'groupDescription': 'at 30 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '5.3', 'ciUpperLimit': '9.4', 'groupDescription': 'at 1 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '5.7', 'ciUpperLimit': '9.9', 'groupDescription': 'at 2 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '5.2', 'ciUpperLimit': '9.4', 'groupDescription': 'at 4 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '5.3', 'ciUpperLimit': '9.5', 'groupDescription': 'at 8 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '4.2', 'ciUpperLimit': '8.4', 'groupDescription': 'at 12 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '2.9', 'ciUpperLimit': '7.2', 'groupDescription': 'at 23 hours 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '3.7', 'ciUpperLimit': '8.0', 'groupDescription': 'at 23 hours 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days', 'unitOfMeasure': 'Percent of predicted', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5648', 'groupId': 'OG000', 'lowerLimit': '3.2407', 'upperLimit': '3.8890'}, {'value': '3.5912', 'groupId': 'OG001', 'lowerLimit': '3.2672', 'upperLimit': '3.9152'}, {'value': '3.3783', 'groupId': 'OG002', 'lowerLimit': '3.0541', 'upperLimit': '3.7024'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5850', 'groupId': 'OG000', 'lowerLimit': '3.2608', 'upperLimit': '3.9091'}, {'value': '3.5773', 'groupId': 'OG001', 'lowerLimit': '3.2531', 'upperLimit': '3.9015'}, {'value': '3.3600', 'groupId': 'OG002', 'lowerLimit': '3.0359', 'upperLimit': '3.6842'}]}]}, {'title': '30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.6068', 'groupId': 'OG000', 'lowerLimit': '3.2827', 'upperLimit': '3.9310'}, {'value': '3.6039', 'groupId': 'OG001', 'lowerLimit': '3.2798', 'upperLimit': '3.9279'}, {'value': '3.3664', 'groupId': 'OG002', 'lowerLimit': '3.0422', 'upperLimit': '3.6905'}]}]}, {'title': '1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5946', 'groupId': 'OG000', 'lowerLimit': '3.2705', 'upperLimit': '3.9188'}, {'value': '3.5886', 'groupId': 'OG001', 'lowerLimit': '3.2645', 'upperLimit': '3.9126'}, {'value': '3.3873', 'groupId': 'OG002', 'lowerLimit': '3.0631', 'upperLimit': '3.7114'}]}]}, {'title': '2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5789', 'groupId': 'OG000', 'lowerLimit': '3.2548', 'upperLimit': '3.9031'}, {'value': '3.5992', 'groupId': 'OG001', 'lowerLimit': '3.2751', 'upperLimit': '3.9233'}, {'value': '3.3987', 'groupId': 'OG002', 'lowerLimit': '3.0745', 'upperLimit': '3.7228'}]}]}, {'title': '4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5674', 'groupId': 'OG000', 'lowerLimit': '3.2433', 'upperLimit': '3.8916'}, {'value': '3.5999', 'groupId': 'OG001', 'lowerLimit': '3.2759', 'upperLimit': '3.9240'}, {'value': '3.4053', 'groupId': 'OG002', 'lowerLimit': '3.0812', 'upperLimit': '3.7295'}]}]}, {'title': '8 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5670', 'groupId': 'OG000', 'lowerLimit': '3.2428', 'upperLimit': '3.8913'}, {'value': '3.5617', 'groupId': 'OG001', 'lowerLimit': '3.2376', 'upperLimit': '3.8858'}, {'value': '3.3680', 'groupId': 'OG002', 'lowerLimit': '3.0438', 'upperLimit': '3.6922'}]}]}, {'title': '12 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4941', 'groupId': 'OG000', 'lowerLimit': '3.1698', 'upperLimit': '3.8183'}, {'value': '3.4812', 'groupId': 'OG001', 'lowerLimit': '3.1571', 'upperLimit': '3.8053'}, {'value': '3.3193', 'groupId': 'OG002', 'lowerLimit': '2.9950', 'upperLimit': '3.6436'}]}]}, {'title': '23 hour 15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.6055', 'groupId': 'OG000', 'lowerLimit': '3.2812', 'upperLimit': '3.9298'}, {'value': '3.5448', 'groupId': 'OG001', 'lowerLimit': '3.2207', 'upperLimit': '3.8689'}, {'value': '3.4199', 'groupId': 'OG002', 'lowerLimit': '3.0952', 'upperLimit': '3.7446'}]}]}, {'title': '23 hour 45 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5668', 'groupId': 'OG000', 'lowerLimit': '3.2425', 'upperLimit': '3.8912'}, {'value': '3.5731', 'groupId': 'OG001', 'lowerLimit': '3.2489', 'upperLimit': '3.8972'}, {'value': '3.4185', 'groupId': 'OG002', 'lowerLimit': '3.0938', 'upperLimit': '3.7431'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1866', 'ciLowerLimit': '0.1121', 'ciUpperLimit': '0.2611', 'groupDescription': '5 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2249', 'ciLowerLimit': '0.1506', 'ciUpperLimit': '0.2992', 'groupDescription': '15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2404', 'ciLowerLimit': '0.1661', 'ciUpperLimit': '0.3148', 'groupDescription': '30 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2074', 'ciLowerLimit': '0.1330', 'ciUpperLimit': '0.2817', 'groupDescription': '1 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1802', 'ciLowerLimit': '0.1059', 'ciUpperLimit': '0.2545', 'groupDescription': '2 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1621', 'ciLowerLimit': '0.0876', 'ciUpperLimit': '0.2366', 'groupDescription': '4 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1990', 'ciLowerLimit': '0.1239', 'ciUpperLimit': '0.2742', 'groupDescription': '8 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1747', 'ciLowerLimit': '0.0994', 'ciUpperLimit': '0.2501', 'groupDescription': '12 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1856', 'ciLowerLimit': '0.1081', 'ciUpperLimit': '0.2631', 'groupDescription': '23 hours 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1484', 'ciLowerLimit': '0.0709', 'ciUpperLimit': '0.2259', 'groupDescription': '23 hours 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2130', 'ciLowerLimit': '0.1386', 'ciUpperLimit': '0.2873', 'groupDescription': '5 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2173', 'ciLowerLimit': '0.1426', 'ciUpperLimit': '0.2920', 'groupDescription': '15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2375', 'ciLowerLimit': '0.1632', 'ciUpperLimit': '0.3118', 'groupDescription': '30 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2013', 'ciLowerLimit': '0.1272', 'ciUpperLimit': '0.2754', 'groupDescription': '1 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2005', 'ciLowerLimit': '0.1262', 'ciUpperLimit': '0.2749', 'groupDescription': '2 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1946', 'ciLowerLimit': '0.1201', 'ciUpperLimit': '0.2691', 'groupDescription': '4 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1937', 'ciLowerLimit': '0.1190', 'ciUpperLimit': '0.2684', 'groupDescription': '8 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1619', 'ciLowerLimit': '0.0870', 'ciUpperLimit': '0.2369', 'groupDescription': '12 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1249', 'ciLowerLimit': '0.0480', 'ciUpperLimit': '0.2018', 'groupDescription': '23 hour 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1546', 'ciLowerLimit': '0.0777', 'ciUpperLimit': '0.2315', 'groupDescription': '23 hour 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 of each of the three treatment periods at at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.', 'unitOfMeasure': 'liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '94.6'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '95.4'}, {'value': '85.3', 'groupId': 'OG002', 'lowerLimit': '81.1', 'upperLimit': '89.6'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000', 'lowerLimit': '86.6', 'upperLimit': '95.1'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '86.5', 'upperLimit': '95.0'}, {'value': '84.9', 'groupId': 'OG002', 'lowerLimit': '80.6', 'upperLimit': '89.1'}]}]}, {'title': '30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '95.9'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '95.7'}, {'value': '85.1', 'groupId': 'OG002', 'lowerLimit': '80.8', 'upperLimit': '89.3'}]}]}, {'title': '1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '95.3'}, {'value': '91.1', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '95.3'}, {'value': '85.6', 'groupId': 'OG002', 'lowerLimit': '81.4', 'upperLimit': '89.8'}]}]}, {'title': '2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '94.9'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '87.1', 'upperLimit': '95.6'}, {'value': '85.9', 'groupId': 'OG002', 'lowerLimit': '81.7', 'upperLimit': '90.2'}]}]}, {'title': '4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '94.8'}, {'value': '91.3', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '95.5'}, {'value': '86.2', 'groupId': 'OG002', 'lowerLimit': '82.0', 'upperLimit': '90.5'}]}]}, {'title': '8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '86.1', 'upperLimit': '94.6'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.1', 'upperLimit': '94.6'}, {'value': '85.4', 'groupId': 'OG002', 'lowerLimit': '81.1', 'upperLimit': '89.6'}]}]}, {'title': '12 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '92.8'}, {'value': '88.2', 'groupId': 'OG001', 'lowerLimit': '84.0', 'upperLimit': '92.5'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '79.8', 'upperLimit': '88.3'}]}]}, {'title': '23 hours 15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '87.2', 'upperLimit': '95.7'}, {'value': '89.9', 'groupId': 'OG001', 'lowerLimit': '85.6', 'upperLimit': '94.1'}, {'value': '86.9', 'groupId': 'OG002', 'lowerLimit': '82.6', 'upperLimit': '91.2'}]}]}, {'title': '23 hours 45 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '94.9'}, {'value': '90.6', 'groupId': 'OG001', 'lowerLimit': '86.4', 'upperLimit': '94.9'}, {'value': '86.5', 'groupId': 'OG002', 'lowerLimit': '82.3', 'upperLimit': '90.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '3.1', 'ciUpperLimit': '7.0', 'groupDescription': '5 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'<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '2.8', 'ciUpperLimit': '6.7', 'groupDescription': '2 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '2.3', 'ciUpperLimit': '6.3', 'groupDescription': '4 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '3', 'ciUpperLimit': '7', 'groupDescription': '8 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 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'ciLowerLimit': '3.9', 'ciUpperLimit': '7.8', 'groupDescription': '5 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '3.9', 'ciUpperLimit': '7.8', 'groupDescription': '15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '4.4', 'ciUpperLimit': '8.3', 'groupDescription': '30 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '3.5', 'ciUpperLimit': '7.5', 'groupDescription': '1 hour', 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'upperLimit': '0.6923'}]}]}, {'title': '30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7012', 'groupId': 'OG000', 'lowerLimit': '0.6761', 'upperLimit': '0.7263'}, {'value': '0.6996', 'groupId': 'OG001', 'lowerLimit': '0.6745', 'upperLimit': '0.7246'}, {'value': '0.6706', 'groupId': 'OG002', 'lowerLimit': '0.6455', 'upperLimit': '0.6957'}]}]}, {'title': '1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7053', 'groupId': 'OG000', 'lowerLimit': '0.6802', 'upperLimit': '0.7304'}, {'value': '0.7007', 'groupId': 'OG001', 'lowerLimit': '0.6757', 'upperLimit': '0.7258'}, {'value': '0.6729', 'groupId': 'OG002', 'lowerLimit': '0.6478', 'upperLimit': '0.6980'}]}]}, {'title': '2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7085', 'groupId': 'OG000', 'lowerLimit': '0.6834', 'upperLimit': '0.7336'}, {'value': '0.7085', 'groupId': 'OG001', 'lowerLimit': '0.6834', 'upperLimit': '0.7335'}, {'value': '0.6747', 'groupId': 'OG002', 'lowerLimit': '0.6496', 'upperLimit': '0.6998'}]}]}, {'title': '4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7057', 'groupId': 'OG000', 'lowerLimit': '0.6806', 'upperLimit': '0.7308'}, {'value': '0.7010', 'groupId': 'OG001', 'lowerLimit': '0.6759', 'upperLimit': '0.7261'}, {'value': '0.6732', 'groupId': 'OG002', 'lowerLimit': '0.6481', 'upperLimit': '0.6984'}]}]}, {'title': '8 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6962', 'groupId': 'OG000', 'lowerLimit': '0.6710', 'upperLimit': '0.7213'}, {'value': '0.6967', 'groupId': 'OG001', 'lowerLimit': '0.6716', 'upperLimit': '0.7218'}, {'value': '0.6651', 'groupId': 'OG002', 'lowerLimit': '0.6399', 'upperLimit': '0.6902'}]}]}, {'title': '12 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6958', 'groupId': 'OG000', 'lowerLimit': '0.6707', 'upperLimit': '0.7210'}, {'value': '0.6885', 'groupId': 'OG001', 'lowerLimit': '0.6634', 'upperLimit': '0.7135'}, {'value': '0.6599', 'groupId': 'OG002', 'lowerLimit': '0.6348', 'upperLimit': '0.6851'}]}]}, {'title': '23 hour 15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6898', 'groupId': 'OG000', 'lowerLimit': '0.6647', 'upperLimit': '0.7150'}, {'value': '0.6853', 'groupId': 'OG001', 'lowerLimit': '0.6602', 'upperLimit': '0.7104'}, {'value': '0.6572', 'groupId': 'OG002', 'lowerLimit': '0.6320', 'upperLimit': '0.6825'}]}]}, {'title': '23 hour 45 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6934', 'groupId': 'OG000', 'lowerLimit': '0.6683', 'upperLimit': '0.7186'}, {'value': '0.6899', 'groupId': 'OG001', 'lowerLimit': '0.6648', 'upperLimit': '0.7150'}, {'value': '0.6633', 'groupId': 'OG002', 'lowerLimit': '0.6381', 'upperLimit': '0.6886'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': 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Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0324', 'ciLowerLimit': '0.0214', 'ciUpperLimit': '0.0434', 'groupDescription': '1 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0338', 'ciLowerLimit': '0.0228', 'ciUpperLimit': '0.0447', 'groupDescription': '2 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0325', 'ciLowerLimit': '0.0215', 'ciUpperLimit': '0.0435', 'groupDescription': '4 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0311', 'ciLowerLimit': '0.0200', 'ciUpperLimit': '0.0422', 'groupDescription': '8 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0359', 'ciLowerLimit': '0.0248', 'ciUpperLimit': '0.0470', 'groupDescription': '12 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0326', 'ciLowerLimit': '0.0211', 'ciUpperLimit': '0.0440', 'groupDescription': '23 hour 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0301', 'ciLowerLimit': '0.0187', 'ciUpperLimit': '0.0415', 'groupDescription': '23 hour 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0222', 'ciLowerLimit': '0.0113', 'ciUpperLimit': '0.0332', 'groupDescription': '5 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0344', 'ciLowerLimit': '0.0234', 'ciUpperLimit': '0.0454', 'groupDescription': '15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0290', 'ciLowerLimit': '0.0180', 'ciUpperLimit': '0.0399', 'groupDescription': '30 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0278', 'ciLowerLimit': '0.0169', 'ciUpperLimit': '0.0387', 'groupDescription': '1 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0338', 'ciLowerLimit': '0.0228', 'ciUpperLimit': '0.0447', 'groupDescription': '2 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0278', 'ciLowerLimit': '0.0168', 'ciUpperLimit': '0.0387', 'groupDescription': '4 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0316', 'ciLowerLimit': '0.0206', 'ciUpperLimit': '0.0426', 'groupDescription': '8 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0285', 'ciLowerLimit': '0.0175', 'ciUpperLimit': '0.0396', 'groupDescription': '12 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0281', 'ciLowerLimit': '0.0167', 'ciUpperLimit': '0.0394', 'groupDescription': '23 hour 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0266', 'ciLowerLimit': '0.0152', 'ciUpperLimit': '0.0379', 'groupDescription': '23 hour 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'title': '5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6968', 'groupId': 'OG000', 'lowerLimit': '1.4675', 'upperLimit': '1.9261'}, {'value': '1.6918', 'groupId': 'OG001', 'lowerLimit': '1.4628', 'upperLimit': '1.9208'}, {'value': '1.4962', 'groupId': 'OG002', 'lowerLimit': '1.2668', 'upperLimit': '1.7256'}]}]}, {'title': '15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7454', 'groupId': 'OG000', 'lowerLimit': '1.5160', 'upperLimit': '1.9747'}, {'value': '1.7458', 'groupId': 'OG001', 'lowerLimit': '1.5165', 'upperLimit': '1.9751'}, {'value': '1.4531', 'groupId': 'OG002', 'lowerLimit': '1.2238', 'upperLimit': '1.6824'}]}]}, {'title': '30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7347', 'groupId': 'OG000', 'lowerLimit': '1.5053', 'upperLimit': '1.9640'}, {'value': '1.7413', 'groupId': 'OG001', 'lowerLimit': '1.5122', 'upperLimit': '1.9704'}, {'value': '1.4690', 'groupId': 'OG002', 'lowerLimit': '1.2397', 'upperLimit': '1.6983'}]}]}, {'title': '1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7715', 'groupId': 'OG000', 'lowerLimit': '1.5422', 'upperLimit': '2.0008'}, {'value': '1.7349', 'groupId': 'OG001', 'lowerLimit': '1.5059', 'upperLimit': '1.9640'}, {'value': '1.4963', 'groupId': 'OG002', 'lowerLimit': '1.2670', 'upperLimit': '1.7256'}]}]}, {'title': '2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7907', 'groupId': 'OG000', 'lowerLimit': '1.5613', 'upperLimit': '2.0200'}, {'value': '1.8074', 'groupId': 'OG001', 'lowerLimit': '1.5782', 'upperLimit': '2.0365'}, {'value': '1.5088', 'groupId': 'OG002', 'lowerLimit': '1.2795', 'upperLimit': '1.7381'}]}]}, {'title': '4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7663', 'groupId': 'OG000', 'lowerLimit': '1.5370', 'upperLimit': '1.9956'}, {'value': '1.7503', 'groupId': 'OG001', 'lowerLimit': '1.5212', 'upperLimit': '1.9795'}, {'value': '1.4843', 'groupId': 'OG002', 'lowerLimit': '1.2549', 'upperLimit': '1.7137'}]}]}, {'title': '8 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6755', 'groupId': 'OG000', 'lowerLimit': '1.4460', 'upperLimit': '1.9050'}, {'value': '1.6774', 'groupId': 'OG001', 'lowerLimit': '1.4483', 'upperLimit': '1.9066'}, {'value': '1.4217', 'groupId': 'OG002', 'lowerLimit': '1.1922', 'upperLimit': '1.6512'}]}]}, {'title': '12 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6549', 'groupId': 'OG000', 'lowerLimit': '1.4254', 'upperLimit': '1.8844'}, {'value': '1.5849', 'groupId': 'OG001', 'lowerLimit': '1.3557', 'upperLimit': '1.8140'}, {'value': '1.3862', 'groupId': 'OG002', 'lowerLimit': '1.1566', 'upperLimit': '1.6158'}]}]}, {'title': '23 hour 15 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6667', 'groupId': 'OG000', 'lowerLimit': '1.4370', 'upperLimit': '1.8964'}, {'value': '1.6257', 'groupId': 'OG001', 'lowerLimit': '1.3965', 'upperLimit': '1.8550'}, {'value': '1.4214', 'groupId': 'OG002', 'lowerLimit': '1.1910', 'upperLimit': '1.6518'}]}]}, {'title': '23 hour 45 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6446', 'groupId': 'OG000', 'lowerLimit': '1.4149', 'upperLimit': '1.8743'}, {'value': '1.6580', 'groupId': 'OG001', 'lowerLimit': '1.4288', 'upperLimit': '1.8873'}, {'value': '1.4584', 'groupId': 'OG002', 'lowerLimit': '1.2280', 'upperLimit': '1.6866'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2025', 'ciLowerLimit': '0.1059', 'ciUpperLimit': '0.2952', 'groupDescription': '5 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2923', 'ciLowerLimit': '0.1979', 'ciUpperLimit': '0.3867', 'groupDescription': '15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2657', 'ciLowerLimit': '0.1713', 'ciUpperLimit': '0.3601', 'groupDescription': '30 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2752', 'ciLowerLimit': '0.1808', 'ciUpperLimit': '0.3696', 'groupDescription': '1 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2819', 'ciLowerLimit': '0.1875', 'ciUpperLimit': '0.3763', 'groupDescription': '2 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2820', 'ciLowerLimit': '0.1874', 'ciUpperLimit': '0.3766', 'groupDescription': '4 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2538', 'ciLowerLimit': '0.1585', 'ciUpperLimit': '0.3492', 'groupDescription': '8 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2687', 'ciLowerLimit': '0.1732', 'ciUpperLimit': '0.3643', 'groupDescription': '12 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2453', 'ciLowerLimit': '0.1473', 'ciUpperLimit': '0.3434', 'groupDescription': '23 hours 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1862', 'ciLowerLimit': '0.0882', 'ciUpperLimit': '0.2842', 'groupDescription': '23 hours 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1956', 'ciLowerLimit': '0.1012', 'ciUpperLimit': '0.2899', 'groupDescription': '5 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2927', 'ciLowerLimit': '0.1979', 'ciUpperLimit': '0.3875', 'groupDescription': '15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2723', 'ciLowerLimit': '0.1780', 'ciUpperLimit': '0.3667', 'groupDescription': '30 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2386', 'ciLowerLimit': '0.1445', 'ciUpperLimit': '0.3328', 'groupDescription': '1 hour', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2986', 'ciLowerLimit': '0.2042', 'ciUpperLimit': '0.3930', 'groupDescription': '2 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2661', 'ciLowerLimit': '0.1715', 'ciUpperLimit': '0.3607', 'groupDescription': '4 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2558', 'ciLowerLimit': '0.1609', 'ciUpperLimit': '0.3506', 'groupDescription': '8 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1987', 'ciLowerLimit': '0.1036', 'ciUpperLimit': '0.2938', 'groupDescription': '12 hours', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2044', 'ciLowerLimit': '0.1071', 'ciUpperLimit': '0.3017', 'groupDescription': '23 hours 15 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1997', 'ciLowerLimit': '0.1023', 'ciUpperLimit': '0.2970', 'groupDescription': '23 hours 45 min', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days', 'unitOfMeasure': 'Liters/second', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5179', 'spread': '0.11213', 'groupId': 'OG000'}, {'value': '2.5151', 'spread': '0.11205', 'groupId': 'OG001'}, {'value': '2.2703', 'spread': '0.11213', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2476', 'ciLowerLimit': '0.1857', 'ciUpperLimit': '0.3095', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2448', 'ciLowerLimit': '0.1830', 'ciUpperLimit': '0.3066', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0028', 'ciLowerLimit': '-0.0647', 'ciUpperLimit': '0.0590', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose to 4 hours post-dose on Day 14 of each of the three treatment periods', 'description': 'Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 μg and placebo, and between indacaterol acetate 150 μg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h)', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '0.228', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.227', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '0.228', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.11', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.11', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days of treatment for each of the three treatment periods', 'description': 'The mean daily number of puffs of rescue medication usage as reported by subjects via diary.', 'unitOfMeasure': 'Puffs', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}, {'type': 'SECONDARY', 'title': 'Mean Overall Peak Expiratory Flow (PEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate 150 µg', 'description': 'indacaterol maleate 150 μg via Breezhaler'}, {'id': 'OG001', 'title': 'Indacaterol Acetate 150 µg', 'description': 'indacaterol acetate 150 μg via Breezhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'matching placebo capsules to indacaterol via Breezhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '409.7', 'spread': '15.06', 'groupId': 'OG000'}, {'value': '407.6', 'spread': '15.05', 'groupId': 'OG001'}, {'value': '376.8', 'spread': '15.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.0', 'ciLowerLimit': '25.6', 'ciUpperLimit': '40.3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.8', 'ciLowerLimit': '23.5', 'ciUpperLimit': '38.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Days 8 through Day 14 of each of the three treatment periods', 'description': 'A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates', 'unitOfMeasure': 'Liters/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'indacaterol maleate 150 μg , indacaterol acetate 150 μg and matching placebo'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'indacaterol acetate 150 μg, matching placebo and indacaterol maleate 150 μg'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': 'Placebo, indacaterol maleate 150 μg and indacaterol acetate 150 μg'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': 'indacaterol maleate 150 μg, placebo, and indacaterol acetate 150 μg'}, {'id': 'FG004', 'title': 'Sequence 5', 'description': 'indacaterol acetate 150 μg, indacaterol maleate 150 μg, and placebo'}, {'id': 'FG005', 'title': 'Sequence 6', 'description': 'Placebo, indacaterol acetate 150 μg, indacaterol maleate 150 μg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants randomized to one of six treatment sequences'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-16', 'size': 1153324, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-08T19:49', 'hasProtocol': False}, {'date': '2017-02-27', 'size': 3864731, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-08T19:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2017-06-06', 'resultsFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-28', 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough FEV1', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics AUC 0-24hours at Steady State', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings'}, {'measure': 'The Maximum Concentration (Cmax) at Steady State (ss)', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings.'}, {'measure': 'Time of Maximal Plasma Concentration (Tmax) at Steady State', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14'}, {'measure': 'The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided.'}, {'measure': 'Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate', 'timeFrame': 'Day 14', 'description': 'Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate.'}, {'measure': 'Time to Peak FEV1 on Day 14', 'timeFrame': 'Day 14 of each of the three treatment periods', 'description': 'The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo'}, {'measure': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1. Day 14, FEV1 was measured at 24hours post dose'}, {'measure': 'Percent of Predicted Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1 (% Predicted) at All Timepoints', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days'}, {'measure': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC)', 'timeFrame': 'Day 14 of each of the three treatment periods at at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.'}, {'measure': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted)', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.'}, {'measure': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1/FVC', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.'}, {'measure': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75%', 'timeFrame': 'Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min', 'description': 'The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days'}, {'measure': 'Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC.', 'timeFrame': 'Pre-dose to 4 hours post-dose on Day 14 of each of the three treatment periods', 'description': 'Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 μg and placebo, and between indacaterol acetate 150 μg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h)'}, {'measure': 'Rescue Medication Usage', 'timeFrame': '14 days of treatment for each of the three treatment periods', 'description': 'The mean daily number of puffs of rescue medication usage as reported by subjects via diary.'}, {'measure': 'Mean Overall Peak Expiratory Flow (PEF)', 'timeFrame': 'Days 8 through Day 14 of each of the three treatment periods', 'description': 'A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma, asthma attack, difficulty breathing, bronchial diseases, lung, lung diseases, inhaled drugs, bronchodilator, inhaled corticosteriod'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '32967685', 'type': 'DERIVED', 'citation': 'Miller D, Vaidya S, Jauernig J, Ethell B, Wagner K, Radhakrishnan R, Tillmann HC. Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients. Respir Res. 2020 Sep 23;21(1):248. doi: 10.1186/s12931-020-01501-1.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=438', 'label': 'A Plain Language Trial Summary is available on novartisclinicatrials.com'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, three-period cross-over study in asthma patients. The study will consist of a screening epoch, followed by a treatment epoch which consists of three treatment periods, and will conclude with an end of study epoch.\n\nEach subject will be assigned to 1 of 6 treatment sequences and will sequentially receive the investigational products and placebo during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male and female patients aged ≥ 18 and above\n* Patients with a documented physician diagnosis of asthma for a period of at least 1 year prior to screening and who additionally meet the following criteria:\n\nPatients receiving daily treatment with an inhaled corticosteroid up to the maximum dose per day (as indicated in the package leaflet), on a stable regimen for at least 4 weeks prior to screening.\n\n* Pre-bronchodilator FEV1 ≥ 50 % and ≤ 90% of the predicted normal value for the patient during screening.\n* Patients who demonstrate an increase in FEV1 of ≥ 12% and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at screening.\n* Subjects must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.\n\nKey Exclusion Criteria:\n\n-Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof: Sympathomimetic amines / adrenoceptor agonist agents Lactose or any of the other excipients of the study drug (including patients with history of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)\n\n* Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of screening.\n* Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to screening.\n* Patients with a history of chronic lung diseases other than asthma\n* Patients who have a decline in PEF from the reference PEF (taken at screening) of ≥30% for 5 of 6 consecutive scheduled PEF readings (readings taken at morning and evening) during at least 3 days of screening epoch prior to randomization.\n* Patients who require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) during screening prior to randomization.\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n* Patients with Type I diabetes or uncontrolled Type II diabetes (HbA1c \\> 9%) at screening.\n* Current smokers (urine cotinine \\> than the laboratory's lowest level of quantification (LoQ of 500 ng/mL or lower)) and patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.)."}, 'identificationModule': {'nctId': 'NCT03257995', 'briefTitle': 'Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Three-period Cross-over Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts (Maleate and Acetate) Delivered Via the Concept1 Inhalation Device in Patients With Asthma', 'orgStudyIdInfo': {'id': 'CQVM149B2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'A-B-C', 'interventionNames': ['Drug: Indacaterol maleate', 'Drug: Indacaterol acetate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'B-C-A', 'interventionNames': ['Drug: Indacaterol maleate', 'Drug: Indacaterol acetate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'C-A-B', 'interventionNames': ['Drug: Indacaterol maleate', 'Drug: Indacaterol acetate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'A-C-B', 'interventionNames': ['Drug: Indacaterol maleate', 'Drug: Indacaterol acetate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': 'B-A-C', 'interventionNames': ['Drug: Indacaterol maleate', 'Drug: Indacaterol acetate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'description': 'C-B-A', 'interventionNames': ['Drug: Indacaterol maleate', 'Drug: Indacaterol acetate', 'Drug: Placebo']}], 'interventions': [{'name': 'Indacaterol maleate', 'type': 'DRUG', 'otherNames': ['A'], 'description': '150 μg via Concept1 device', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Indacaterol acetate', 'type': 'DRUG', 'otherNames': ['B'], 'description': '150 μg via Concept1 device', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['C'], 'description': 'Capsule containing no active ingredients delivered via Concept1 device', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02747-3322', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08558', 'city': 'Skillman', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.42011, 'lon': -74.7146}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '79903', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}