Pulmonary Disease, Chronic Obstructive
Conditions
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
Interventions
DRUGDrug: Berodual®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of either sex, including children over 6 years * Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)
Exclusion criteria
* Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall severity of the clinical picture rated on a 4-point scale | after 3 and 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of dyspnea episodes rated on a 4-point scale | after 3 and 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 rated on a 4-point scale | after 3 and 6 weeks |
| Assessment of tolerability on a 4-point scale | after 3 and 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 |
| Changes in dyspnea and/or asthma attacks rated on a 4-point scale | after 3 and 6 weeks |
| Number of patients with adverse drug reactions | up to 6 weeks |
Outcome results
None listed