Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-25 @ 7:51 PM
Study NCT ID:
NCT00615459
Status:
COMPLETED
Last Update Posted:
2011-08-17
First Post:
2008-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
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'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, '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': {'timeFrame': '10 weeks', 'description': 'In the safety population, all patients were analyzed according to treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Indacaterol 150 μg', 'description': 'Indacaterol 150 μg once daily delivered via single dose dry powder inhaler (SDDPI) and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.', 'otherNumAtRisk': 118, 'otherNumAffected': 15, 'seriousNumAtRisk': 118, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.', 'otherNumAtRisk': 122, 'otherNumAffected': 17, 'seriousNumAtRisk': 122, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Tiotropium 18 μg', 'description': 'Tiotropium 18 μg once daily delivered via inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.', 'otherNumAtRisk': 120, 'otherNumAffected': 11, 'seriousNumAtRisk': 120, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.', 'otherNumAtRisk': 123, 'otherNumAffected': 13, 'seriousNumAtRisk': 123, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Tiotropium 18 μg', 'description': 'Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.53', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.021', 'groupId': 'OG001'}, {'value': '1.48', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '1.36', 'spread': '0.021', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug. Patients were analyzed according to treatment they received.'}, {'type': 'SECONDARY', 'title': 'Peak FEV1 During 4 Hours Post Morning Dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Indacaterol 150 μg', 'description': 'Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}, {'id': 'OG001', 'title': 'Indacaterol 300 μg', 'description': 'Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}, {'id': 'OG002', 'title': 'Tiotropium 18 μg', 'description': 'Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '1.62', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '1.48', 'spread': '0.015', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (from 0 to 4 hours post morning dose)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population, included all randomized patients who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg', 'description': 'In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.'}, {'id': 'FG001', 'title': 'Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium', 'description': 'In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.'}, {'id': 'FG002', 'title': 'Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo', 'description': 'In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.'}, {'id': 'FG003', 'title': 'Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg', 'description': 'In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.'}], 'periods': [{'title': 'Period I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'comment': '1 randomized patient of this sequence was never exposed to drug. Hence, dropped out before Period I.', 'groupId': 'FG001', 'numSubjects': '41'}, {'comment': '1 randomized patient of this sequence was never exposed to drug. Hence, dropped out before Period I.', 'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Abnormal test procedure results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period III', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were randomized to one of the 4 possible treatment sequences of the double-blind 10-week treatment phase (Week 1 - 10) to receive three out of the four study treatments. Each treatment sequence was divided into three 2-week treatment periods (I/II/III), with periods I and II followed by 2-week washout periods.', 'preAssignmentDetails': 'Out of total 169 randomized patients, two patients were discontinued before exposure to any treatment in period I because of administrative problems.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Patients', 'description': 'The safety population, included all patients who received at least one dose of study drug.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '7.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-22', 'studyFirstSubmitDate': '2008-02-01', 'resultsFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-22', 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment', 'timeFrame': '23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of FEV1 measurements at 23 h 10 min and 23 h 45 min post Day 14 dose measured on the morning of Day 15 in each treatment period. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.'}], 'secondaryOutcomes': [{'measure': 'Peak FEV1 During 4 Hours Post Morning Dose on Day 1', 'timeFrame': 'Day 1 (from 0 to 4 hours post morning dose)', 'description': 'FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect on Day 1 was defined as the maximum FEV1 during the first 4 hour on that day. FEV1 measurements taken within 6 hour of rescue use were set to missing before the peak FEV1 (0-4 hour) was calculated. The model used for analysis contained the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '20920365', 'type': 'DERIVED', 'citation': 'Vogelmeier C, Ramos-Barbon D, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INTIME study investigators (INdacaterol & TIotropium: Measuring Efficacy). Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res. 2010 Oct 5;11(1):135. doi: 10.1186/1465-9921-11-135.'}]}, 'descriptionModule': {'briefSummary': 'The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure\n* Co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:\n\n 1. Smoking history of at least 10 pack years (current or previous smokers)\n 2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \\< 80% and ≥30% of the predicted normal value.\n 3. Post-bronchodilator FEV1/Forced vital capacity (FVC) \\< 70%\n\nExclusion Criteria:\n\n* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period\n* Patients requiring long-term oxygen therapy for chronic hypoxemia\n* Patients who have had a respiratory tract infection within 6 weeks prior to Visit\n* Patients with concomitant pulmonary disease\n* Patients with a history of asthma\n* Patients with diabetes Type I or uncontrolled diabetes Type II\n* Any patient with lung cancer or a history of lung cancer\n* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time\n* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or randomization is prolonged\n* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.\n* Patients unable to successfully use a dry powder inhaler device, MDI or perform spirometry measurements\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00615459', 'briefTitle': 'A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control', 'orgStudyIdInfo': {'id': 'CQAB149B2331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg', 'description': 'In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Tiotropium', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium', 'description': 'In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Tiotropium']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo', 'description': 'In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg', 'description': 'In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.', 'interventionNames': ['Drug: Indacaterol', 'Drug: Tiotropium', 'Drug: Placebo']}], 'interventions': [{'name': 'Indacaterol', 'type': 'DRUG', 'description': 'Indacaterol 150 μg or 300 μg, delivered via SDDPI', 'armGroupLabels': ['Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg', 'Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium', 'Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo', 'Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg']}, {'name': 'Tiotropium', 'type': 'DRUG', 'description': 'Tiotropium 18 μg once daily delivered via inhalation device', 'armGroupLabels': ['Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg', 'Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium', 'Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': "Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)", 'armGroupLabels': ['Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg', 'Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo', 'Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Camperdown', 'country': 'Australia', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'city': 'Gauting', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Novartis Investigator site', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Almelo', 'country': 'Netherlands', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.35667, 'lon': 6.6625}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Harderwijk', 'country': 'Netherlands', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'city': 'Helmond', 'country': 'Netherlands', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'A Coruña', 'country': 'Spain', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Cacenes', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Ourense', 'country': 'Spain', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}], 'overallOfficials': [{'name': 'Novartis Pharma', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}