Post-marketing Surveillance of Ventilat® Metered Dose Inhaler in Chronic Obstructive Bronchitis
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT02233920
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of daily practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 716
Inclusion Criteria
- Primarily Patients of both genders older than 40 years, who suffer from Chronic Obstructive bronchitis
- Only patients who have not been treated with an anticholinergic within the last year are to be considered for inclusion
Exclusion Criteria
•Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic obstructive bronchitis patients Ventilat® - metered dose inhaler -
- Primary Outcome Measures
Name Time Method Change in the clinical picture after 4 weeks
- Secondary Outcome Measures
Name Time Method Assessment of efficacy by investigator on a 4-point scale after 4 weeks Assessment of tolerability by investigator on a 4-point scale after 4 weeks Assessment of efficacy by patient on a 4-point scale after 4 weeks Number of patients with adverse drug reactions up to 4 weeks Assessment of patient by investigator on a 4-point scale after 4 weeks