Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease
Overview
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
Full Title of Study: “Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: November 1999
Interventions
- Drug: Berodual®
Arms, Groups and Cohorts
- chronic obstructive respiratory tract disease patients
Clinical Trial Outcome Measures
Primary Measures
- Overall severity of the clinical picture rated on a 4-point scale
- Time Frame: after 3 and 6 weeks
Secondary Measures
- Changes in dyspnea and/or asthma attacks rated on a 4-point scale
- Time Frame: after 3 and 6 weeks
- Number of dyspnea episodes rated on a 4-point scale
- Time Frame: after 3 and 6 weeks
- Number of awakenings due to night-time dyspnea rated on a 4-point scale
- Time Frame: after 3 and 6 weeks
- Assessment of morning coughing with expectoration on a 4-point scale
- Time Frame: after 3 and 6 weeks
- Assessment of tolerability on a 4-point scale
- Time Frame: after 3 and 6 weeks
- Number of patients with adverse drug reactions
- Time Frame: up to 6 weeks
- Changes in pathological auscultation findings rated on a 3-point scale
- Time Frame: after 3 and 6 weeks
- Changes in concomitant medication
- Time Frame: up to 6 weeks
- Assessment of efficacy on a 4-point scale
- Time Frame: after 3 and 6 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Boehringer Ingelheim
- Provider of Information About this Clinical Study
- Sponsor
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