Pulmonary Disease, Chronic Obstructive
Conditions
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
Interventions
DRUGBerodual®
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 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
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 on a 4-point scale | after 3 and 6 weeks |
| Assessment of tolerability on a 4-point scale | after 3 and 6 weeks |
| Changes in dyspnea and/or asthma attacks rated 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 |
| Assessment of efficacy 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