Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02238132
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2014-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Airways Disease
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 374}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile', 'timeFrame': 'Up to 4 weeks after first study drug administration'}], 'secondaryOutcomes': [{'measure': 'Investigator assessment of efficacy on a 4-point scale', 'timeFrame': 'Up to 4 weeks after first study drug administration'}, {'measure': 'Investigator assessment of tolerability on a 4-point scale', 'timeFrame': 'Up to 4 weeks after first study drug administration'}, {'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'Up to 4 weeks after first study drug administration'}, {'measure': 'Number of patients who withdrew from the study', 'timeFrame': 'Up to 4 weeks after first study drug administration'}, {'measure': 'Number of patients who changed the concomitant medication', 'timeFrame': 'Up to 4 weeks after first study drug administration'}, {'measure': 'Number of patients who continued the treatment', 'timeFrame': 'Up to 4 weeks after first study drug administration'}, {'measure': 'Patient assessment of efficacy on a 4-point scale', 'timeFrame': 'Up to 4 weeks after first study drug administration'}, {'measure': 'Patient assessment of tolerability on a 4-point scale', 'timeFrame': 'Up to 4 weeks after first study drug administration'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic obstructive airways disease recruited at general practitioners, pneumologists, internists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primarily, Patients with chronic obstructive airways disease\n* Only patients who had not been treated with Atrovent® in the last year were to be considered for inclusion\n\nExclusion Criteria:\n\n\\- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® inhalets'}, 'identificationModule': {'nctId': 'NCT02238132', 'briefTitle': 'Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Airways Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Airways Disease', 'orgStudyIdInfo': {'id': '244.2491'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Obstructive Airways Disease', 'interventionNames': ['Drug: ATROVENT® inhalets']}], 'interventions': [{'name': 'ATROVENT® inhalets', 'type': 'DRUG', 'armGroupLabels': ['Chronic Obstructive Airways Disease']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}