Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice
Interventions
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms * Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included
Exclusion criteria
* Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in overall severity of clinical picture rated on 3-point scale | up to 12 weeks |
| Change in breathlessness rated on a 4-point scale | up to 12 weeks |
| Change in restriction of activity due to breathlessness rated on a 4-point scale | up to 12 weeks |
| Change in number of awakening due to nocturnal breathlessness rated on 4-point scale | up to 12 weeks |
| Global assessment of efficacy by the patients rated on 5-point scale | after 4, 8 and 12 weeks |
| Global assessment of efficacy by the investigator rated on 5-point scale | after 4, 8 and 12 weeks |
| Number of patients with adverse drug reactions | up to 12 weeks |
| Assessment of tolerability on a 5-point scale | after 4, 8 and 12 weeks |
Outcome results
None listed