Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
NCT number | NCT02232594 |
Other study ID # | 215.1358 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | September 4, 2014 |
Last updated | September 4, 2014 |
Start date | January 2000 |
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
Status | Completed |
Enrollment | 834 |
Est. completion date | |
Est. primary completion date | December 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease - Only patients which have not been treated with Berodual® within the last year should be included Exclusion Criteria: - Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall severity of the clinical picture rated on a 4- point scale | after 3 and 6 weeks | No | |
Secondary | Assessment of efficacy by investigator on a 4-point scale | after 3 and 6 weeks | No | |
Secondary | Assessment of efficacy by patient on a 4-point scale | after 3 and 6 weeks | No | |
Secondary | Assessment of tolerability by investigator on a 4-point scale | after 3 and 6 weeks | No | |
Secondary | Assessment of tolerability by patient on a 4-point scale | after 3 and 6 weeks | No | |
Secondary | Number of patients with adverse drug reactions | up to 6 weeks | No |
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