Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-28 @ 2:50 AM
Study NCT ID:
NCT02231359
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Berodual® Respimat® Solution for Inhalation in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2006}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, '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': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in overall severity of clinical picture rated on 3-point scale', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change in breathlessness rated on a 4-point scale', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change in restriction of activity due to breathlessness rated on a 4-point scale', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change in number of awakening due to nocturnal breathlessness rated on 4-point scale', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Global assessment of efficacy by the patients rated on 5-point scale', 'timeFrame': 'after 4, 8 and 12 weeks'}, {'measure': 'Global assessment of efficacy by the investigator rated on 5-point scale', 'timeFrame': 'after 4, 8 and 12 weeks'}, {'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Assessment of tolerability on a 5-point scale', 'timeFrame': 'after 4, 8 and 12 weeks'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosis chronic obstructive airways disease recruited at general practitioners, internal specialists and specialists in pneumology in practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms\n* Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included\n\nExclusion Criteria:\n\n* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information'}, 'identificationModule': {'nctId': 'NCT02231359', 'briefTitle': 'Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease', 'orgStudyIdInfo': {'id': '215.1363'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic obstructive airways disease patients', 'interventionNames': ['Drug: Berodual® Respimat® solution for inhalation']}], 'interventions': [{'name': 'Berodual® Respimat® solution for inhalation', 'type': 'DRUG', 'armGroupLabels': ['chronic obstructive airways disease patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}