Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-30 @ 9:56 AM
Study NCT ID:
NCT01232894
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2010-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510790', 'term': 'indacaterol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '41 61 324 1111', 'title': 'Study Director', 'organization': 'Novartis'}, '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': {'timeFrame': 'Entire duration of study', 'description': 'Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol', 'description': 'indacaterol 150 µg once-daily via single-dose dry powder inhaler', 'otherNumAtRisk': 59, 'otherNumAffected': 9, 'seriousNumAtRisk': 59, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Long-acting beta2-agonist', 'description': "Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy", 'otherNumAtRisk': 28, 'otherNumAffected': 4, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain stem haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline on Clinical COPD Questionnaire (CCQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol', 'description': 'indacaterol 150 µg once-daily via single-dose dry powder inhaler'}, {'id': 'OG001', 'title': 'Long-acting beta2-agonist', 'description': "Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy"}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': "The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Indacaterol', 'description': 'indacaterol 150 µg once-daily via single-dose dry powder inhaler'}, {'id': 'FG001', 'title': 'Long-acting beta2-agonist', 'description': "Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '90 participants were screened and enrolled into the study. The participants were randomized in a 2:1 ratio. Out of 90 participants randomized, 87 received study drug and were included in the Safety set for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Indacaterol', 'description': 'indacaterol 150 µg once-daily via single-dose dry powder inhaler'}, {'id': 'BG001', 'title': 'Long-acting beta2-agonist', 'description': "Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2010-11-01', 'resultsFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-18', 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline on Clinical COPD Questionnaire (CCQ) Score', 'timeFrame': 'Baseline and 12 weeks', 'description': "The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['indacaterol', 'COPD', 'Long-acting beta2-agonist (LABA)'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:\n* Post-bronchodilator forced expiratory volume in 1 second (FEV1) \\<80% and ≥30% of the predicted normal value\n* Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \\<70%\n* Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)\n\nExclusion Criteria:\n\n* Patients with a history of asthma\n* Patients who are currently being treated for COPD with tiotropium (Spiriva®)\n* Patients with diabetes Type I or uncontrolled diabetes Type II\n* Patients with a history of certain cardiovascular comorbid conditions\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01232894', 'acronym': 'MOVE-ON', 'briefTitle': '12-week Open-label Evaluation of Efficacy and Safety of Indacaterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12 Week, Multi-center, Randomized, Open Label Study, eValuating the Efficacy and Safety of Treatment Regimens That Include ONbrez (Indacaterol) in Patients With Moderate to Severe COPD (MOVE-ON Study)', 'orgStudyIdInfo': {'id': 'CQAB149BIL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indacaterol', 'description': 'Indacaterol 150 µg once-daily via single-dose dry powder inhaler', 'interventionNames': ['Drug: Indacaterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long-acting beta2-agonist', 'description': "Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy", 'interventionNames': ['Drug: Long-acting beta2-agonist']}], 'interventions': [{'name': 'Indacaterol', 'type': 'DRUG', 'description': 'Indacaterol 150 µg once-daily via single-dose dry powder inhaler', 'armGroupLabels': ['Indacaterol']}, {'name': 'Long-acting beta2-agonist', 'type': 'DRUG', 'description': 'Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily', 'armGroupLabels': ['Long-acting beta2-agonist']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'city': 'Holon', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Rehovot', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}