Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT02231320
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2014-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Pulmonary 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': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-02', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 8 weeks'}, {'measure': 'Number of patients who premature discontinued therapy with Berodual® Respimat®', 'timeFrame': 'up to 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of patient satisfaction with regard to handling of Berodual® Respimat® inhaler', 'timeFrame': 'up to 8 weeks', 'description': 'by means of patient satisfaction and preference questionnaire (PASAPQ)'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'New perceptions about handling and patient satisfaction of the everyday use of Berodual® Respimat® in patients with chronic obstructive lung disease (COLD). Moreover, further knowledge should be attained about the tolerability of Berodual® Respimat®'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosis of chronic obstructive pulmonary disease recruited at pneumologists in practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged at least 18 years who were suffering from symptoms of a COLD (naive or pre-treated) could be included in the PMS\n\nExclusion Criteria:\n\n* Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SmPC) are excluded from the Postmarketing Surveillance (PMS)'}, 'identificationModule': {'nctId': 'NCT02231320', 'briefTitle': 'Postmarketing Surveillance Study to Assess Handling and Patient Satisfaction on Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Berodual® Respimat® 20/50 Microgram/Dose Solution for Inhalation: Assessment of Handling and Patient Satisfaction', 'orgStudyIdInfo': {'id': '215.1367'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Obstructive Pulmonary Disease patients', 'interventionNames': ['Drug: Berodual® Respimat® - inhaler']}], 'interventions': [{'name': 'Berodual® Respimat® - inhaler', 'type': 'DRUG', 'armGroupLabels': ['Chronic Obstructive Pulmonary Disease patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}