Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Berodual®
- Registration Number
- NCT02232594
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 834
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description chronic obstructive respiratory tract disease patients Berodual® -
- Primary Outcome Measures
Name Time Method Overall severity of the clinical picture rated on a 4- point scale after 3 and 6 weeks
- Secondary Outcome Measures
Name Time Method Assessment of efficacy by investigator on a 4-point scale after 3 and 6 weeks Assessment of tolerability by patient on a 4-point scale after 3 and 6 weeks Number of patients with adverse drug reactions up to 6 weeks Assessment of efficacy by patient on a 4-point scale after 3 and 6 weeks Assessment of tolerability by investigator on a 4-point scale after 3 and 6 weeks