Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Berodual®
- Registration Number
- NCT02231437
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this post-marketing surveillance is to obtain further information about the tolerability 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
- 3488
Inclusion Criteria
- Patients with diagnosis of Chronic obstructive respiratory tract disease
- Patients of either sex, including children over 6 years
Exclusion Criteria
- Contraindications listed in the Instructions of Use/Summary of Product Characteristics of 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 Changes in dyspnea and/or asthma attacks rated on a 4-point scale after 3 and 6 weeks Assessment of tolerability on a 4-point scale after 3 and 6 weeks Number of dyspnea episodes rated on a 4-point scale after 3 and 6 weeks Number of patients with adverse drug reactions up to 6 weeks Assessment of efficacy on a 4-point scale after 3 and 6 weeks Changes in pathological auscultation findings rated on a 3-point scale after 3 and 6 weeks Changes in concomitant medication up to 6 weeks Number of awakenings due to night-time dyspnea rated on a 4-point scale after 3 and 6 weeks Assessment of morning coughing with expectoration on a 4-point scale after 3 and 6 weeks