Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-14 @ 1:40 AM
Study NCT ID:
NCT00098228
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2004-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 686}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-24', 'studyFirstSubmitDate': '2004-12-03', 'studyFirstSubmitQcDate': '2004-12-03', 'lastUpdatePostDateStruct': {'date': '2011-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function measured between 22 and 24 hours after dosing on Day 1'}], 'secondaryOutcomes': [{'measure': 'Pulmonary function measured on days 1 and 7 at various intervals after dosing'}, {'measure': 'Safety measurements'}]}, 'conditionsModule': {'keywords': ['COPD, adults, QAB149'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple dose inhaler for use in the COPD Phase III program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD\n* Age 40-75 years\n* Smoking history\n\nExclusion Criteria:\n\n* Other serious disease\n* Allergy to QAB149\n* Respiratory tract infection'}, 'identificationModule': {'nctId': 'NCT00098228', 'briefTitle': 'Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Dose-Ranging Study in Patients With COPD', 'orgStudyIdInfo': {'id': 'CQAB149B2205'}}, 'armsInterventionsModule': {'interventions': [{'name': 'QAB149', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0012', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Pulmonary Research', 'geoPoint': {'lat': 33.52066, 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