Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 6:57 PM
Study NCT ID:
NCT00605306
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2008-01-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068656', 'term': 'Mometasone Furoate'}, {'id': 'C000600413', 'term': 'QMF149'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol Maleate/Mometasone Furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.', 'otherNumAtRisk': 14, 'otherNumAffected': 9, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.', 'otherNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peak expiratory flow rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Painful respiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate/Mometasone Furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AE resulting in discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 days', 'description': 'An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.\n\nA serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Levels of Serum Potassium Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate/Mometasone Furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.'}], 'classes': [{'title': 'Baseline (N=14, 14)', 'categories': [{'measurements': [{'value': '4.271', 'spread': '0.2867', 'groupId': 'OG000'}, {'value': '4.336', 'spread': '0.3388', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, pre-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.264', 'spread': '0.2240', 'groupId': 'OG000'}, {'value': '4.279', 'spread': '0.3446', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 0.25 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.293', 'spread': '0.3583', 'groupId': 'OG000'}, {'value': '4.314', 'spread': '0.5803', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 0.5 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.150', 'spread': '0.2442', 'groupId': 'OG000'}, {'value': '4.179', 'spread': '0.3093', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 1 hour post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.143', 'spread': '0.2174', 'groupId': 'OG000'}, {'value': '4.171', 'spread': '0.2614', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 2 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.157', 'spread': '0.2709', 'groupId': 'OG000'}, {'value': '4.093', 'spread': '0.2200', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 4 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '3.979', 'spread': '0.2486', 'groupId': 'OG000'}, {'value': '3.929', 'spread': '0.2494', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 12 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.436', 'spread': '0.2530', 'groupId': 'OG000'}, {'value': '4.500', 'spread': '0.2961', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 24 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.293', 'spread': '0.2786', 'groupId': 'OG000'}, {'value': '4.386', 'spread': '0.4753', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, pre-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.150', 'spread': '0.3205', 'groupId': 'OG000'}, {'value': '4.136', 'spread': '0.3079', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 0.25 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '4.064', 'spread': '0.3522', 'groupId': 'OG000'}, {'value': '4.092', 'spread': '0.3353', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 0.5 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '3.986', 'spread': '0.3325', 'groupId': 'OG000'}, {'value': '4.092', 'spread': '0.3378', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 1 hour post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '3.986', 'spread': '0.3880', 'groupId': 'OG000'}, {'value': '4.038', 'spread': '0.4426', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 2 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '3.986', 'spread': '0.2627', 'groupId': 'OG000'}, {'value': '4.038', 'spread': '0.3927', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 4 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '3.800', 'spread': '0.3397', 'groupId': 'OG000'}, {'value': '3.792', 'spread': '0.2397', 'groupId': 'OG001'}]}]}, {'title': 'End of study (N=14, 14)', 'categories': [{'measurements': [{'value': '4.364', 'spread': '0.2373', 'groupId': 'OG000'}, {'value': '4.429', 'spread': '0.4103', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).', 'description': 'At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Levels of Plasma Glucose Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate/Mometasone Furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.'}], 'classes': [{'title': 'Baseline (N=14, 14)', 'categories': [{'measurements': [{'value': '5.079', 'spread': '0.3239', 'groupId': 'OG000'}, {'value': '5.157', 'spread': '0.4415', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, pre-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '5.057', 'spread': '0.2533', 'groupId': 'OG000'}, {'value': '5.236', 'spread': '0.3855', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 0.25 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '5.007', 'spread': '0.2786', 'groupId': 'OG000'}, {'value': '5.264', 'spread': '0.4069', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 0.5 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '4.950', 'spread': '0.2279', 'groupId': 'OG000'}, {'value': '5.207', 'spread': '0.3385', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 1 hour post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '5.036', 'spread': '0.2620', 'groupId': 'OG000'}, {'value': '5.193', 'spread': '0.3316', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 2 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '5.057', 'spread': '0.2377', 'groupId': 'OG000'}, {'value': '5.179', 'spread': '0.3142', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 4 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '7.064', 'spread': '1.4532', 'groupId': 'OG000'}, {'value': '6.793', 'spread': '1.2344', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 12 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '5.221', 'spread': '0.2326', 'groupId': 'OG000'}, {'value': '5.286', 'spread': '0.3009', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 24 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '5.293', 'spread': '0.4463', 'groupId': 'OG000'}, {'value': '5.321', 'spread': '0.5767', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, pre-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '5.129', 'spread': '0.4681', 'groupId': 'OG000'}, {'value': '5.221', 'spread': '0.3534', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 0.25 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '5.136', 'spread': '0.4986', 'groupId': 'OG000'}, {'value': '4.900', 'spread': '0.4301', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 0.5 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '5.157', 'spread': '0.4767', 'groupId': 'OG000'}, {'value': '4.946', 'spread': '0.4409', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 1 hour post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '5.136', 'spread': '0.4448', 'groupId': 'OG000'}, {'value': '4.962', 'spread': '0.3841', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 2 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '5.093', 'spread': '0.3269', 'groupId': 'OG000'}, {'value': '4.908', 'spread': '0.4173', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 4 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '6.929', 'spread': '1.3176', 'groupId': 'OG000'}, {'value': '7.408', 'spread': '1.0649', 'groupId': 'OG001'}]}]}, {'title': 'End of study (N=14, 13)', 'categories': [{'measurements': [{'value': '5.257', 'spread': '0.2821', 'groupId': 'OG000'}, {'value': '5.731', 'spread': '1.0160', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).', 'description': 'At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Levels of Serum Cortisol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol Maleate/Mometasone Furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.'}], 'classes': [{'title': 'Baseline (N=14, 14)', 'categories': [{'measurements': [{'value': '466.214', 'spread': '178.2311', 'groupId': 'OG000'}, {'value': '441.143', 'spread': '97.5365', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, pre-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '159.643', 'spread': '100.4533', 'groupId': 'OG000'}, {'value': '140.714', 'spread': '47.2024', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 0.25 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '153.786', 'spread': '87.5313', 'groupId': 'OG000'}, {'value': '151.000', 'spread': '91.2798', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 0.5 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '130.143', 'spread': '74.2375', 'groupId': 'OG000'}, {'value': '130.571', 'spread': '63.6779', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 1 hour post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '99.143', 'spread': '54.5412', 'groupId': 'OG000'}, {'value': '131.929', 'spread': '51.4923', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 2 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '65.357', 'spread': '33.1143', 'groupId': 'OG000'}, {'value': '84.286', 'spread': '27.1220', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, 4 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '55.929', 'spread': '24.6716', 'groupId': 'OG000'}, {'value': '102.071', 'spread': '54.8248', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 11 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '362.500', 'spread': '159.3891', 'groupId': 'OG000'}, {'value': '478.214', 'spread': '121.2272', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 12 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '289.929', 'spread': '96.3906', 'groupId': 'OG000'}, {'value': '404.214', 'spread': '123.4623', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 13 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '335.214', 'spread': '150.7811', 'groupId': 'OG000'}, {'value': '370.071', 'spread': '105.2451', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, 24 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '136.857', 'spread': '75.4442', 'groupId': 'OG000'}, {'value': '193.500', 'spread': '87.5238', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, pre-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '126.071', 'spread': '65.6546', 'groupId': 'OG000'}, {'value': '122.857', 'spread': '71.5379', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 0.25 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '111.500', 'spread': '82.9001', 'groupId': 'OG000'}, {'value': '127.231', 'spread': '104.5834', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 0.5 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '99.500', 'spread': '68.5608', 'groupId': 'OG000'}, {'value': '121.154', 'spread': '112.2726', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 1 hour post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '82.786', 'spread': '57.7663', 'groupId': 'OG000'}, {'value': '106.385', 'spread': '118.7936', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 2 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '62.071', 'spread': '44.5861', 'groupId': 'OG000'}, {'value': '94.154', 'spread': '133.8300', 'groupId': 'OG001'}]}]}, {'title': 'Day 14, 4 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '48.214', 'spread': '34.5280', 'groupId': 'OG000'}, {'value': '102.154', 'spread': '80.7051', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, 11 hours post-dose (N=14, 14)', 'categories': [{'measurements': [{'value': '242.143', 'spread': '177.3739', 'groupId': 'OG000'}, {'value': '417.000', 'spread': '100.8312', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, 12 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '255.500', 'spread': '154.1442', 'groupId': 'OG000'}, {'value': '388.769', 'spread': '104.6885', 'groupId': 'OG001'}]}]}, {'title': 'Day 15, 13 hours post-dose (N=14, 13)', 'categories': [{'measurements': [{'value': '324.857', 'spread': '179.8713', 'groupId': 'OG000'}, {'value': '385.769', 'spread': '126.2301', 'groupId': 'OG001'}]}]}, {'title': 'End of study (N=14, 14)', 'categories': [{'measurements': [{'value': '495.286', 'spread': '259.2054', 'groupId': 'OG000'}, {'value': '417.786', 'spread': '164.1046', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).', 'description': 'At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol Maleate/Mometasone Furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol Maleate/Mometasone Furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'spread': '7.18', 'groupId': 'BG000'}, {'value': '33.9', 'spread': '13.35', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '10.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-11', 'studyFirstSubmitDate': '2008-01-18', 'resultsFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2008-01-30', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-11', 'studyFirstPostDateStruct': {'date': '2008-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Adverse Events', 'timeFrame': '15 days', 'description': 'An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.\n\nA serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.'}], 'secondaryOutcomes': [{'measure': 'Levels of Serum Potassium Over Time', 'timeFrame': 'Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).', 'description': 'At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.'}, {'measure': 'Levels of Plasma Glucose Over Time', 'timeFrame': 'Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).', 'description': 'At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.'}, {'measure': 'Levels of Serum Cortisol Over Time', 'timeFrame': 'Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).', 'description': 'At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'spirometry', 'lung function', 'serum cortisol', 'serum potassium', 'plasma glucose'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adult patients aged 18-65 years (inclusive)\n* Patients with mild-moderate asthma\n* Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.\n* Body mass index (BMI) must be within the range of 18-32 kg/m\\^2.\n* Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.\n\nExclusion Criteria:\n\n* Patients who suffer from chronic obstructive pulmonary disease (COPD)\n* Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start\n* QTcF interval \\> 450 msec in men and \\>470 msec in women\n* Pregnant women or nursing mothers\n* Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).\n* History of immunocompromise, including a positive human immunodeficiency virus (HIV)\n* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.\n* History of drug or alcohol abuse within 12 months of dosing\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00605306', 'briefTitle': 'Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients', 'orgStudyIdInfo': {'id': 'CQMF149A2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'indacaterol maleate/mometasone furoate', 'description': 'Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.', 'interventionNames': ['Drug: indacaterol maleate / mometasone furoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.', 'interventionNames': ['Drug: placebo to indacaterol maleate/mometasone furoate']}], 'interventions': [{'name': 'indacaterol maleate / mometasone furoate', 'type': 'DRUG', 'otherNames': ['QMF149'], 'description': 'Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.', 'armGroupLabels': ['indacaterol maleate/mometasone furoate']}, {'name': 'placebo to indacaterol maleate/mometasone furoate', 'type': 'DRUG', 'description': 'Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neuil', 'country': 'France', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 47.17219, 'lon': 0.51155}}, {'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'NOVARTIS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis investigator site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}