Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT02232594
Status:
COMPLETED
Last Update Posted:
2014-09-05
First Post:
2014-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030809', 'term': 'fenoterol, ipratropium drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 834}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-04', 'studyFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2014-09-04', 'lastUpdatePostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall severity of the clinical picture rated on a 4- point scale', 'timeFrame': 'after 3 and 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of efficacy by investigator on a 4-point scale', 'timeFrame': 'after 3 and 6 weeks'}, {'measure': 'Assessment of efficacy by patient on a 4-point scale', 'timeFrame': 'after 3 and 6 weeks'}, {'measure': 'Assessment of tolerability by investigator on a 4-point scale', 'timeFrame': 'after 3 and 6 weeks'}, {'measure': 'Assessment of tolerability by patient on a 4-point scale', 'timeFrame': 'after 3 and 6 weeks'}, {'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'up to 6 weeks'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic obstructive respiratory tract disease recruited at general physicians and internists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease\n* Only patients which have not been treated with Berodual® within the last year should be included\n\nExclusion Criteria:\n\n* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler'}, 'identificationModule': {'nctId': 'NCT02232594', 'briefTitle': 'Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease', 'orgStudyIdInfo': {'id': '215.1358'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic obstructive respiratory tract disease patients', 'interventionNames': ['Drug: Berodual®']}], 'interventions': [{'name': 'Berodual®', 'type': 'DRUG', 'armGroupLabels': ['chronic obstructive respiratory tract disease patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}