Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler
Interventions
DRUGBerotec® N 100 µg Metered-dose Inhaler
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler
Exclusion criteria
• Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the clinical picture of chronic obstructive airways disease on switching from Berotec® 200 µg to Berotec® N 100 µg | After 3 weeks of first drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Patient assessment of efficacy on a 4-point scale | Up to 3 weeks after first drug administration |
| Patient assessment of tolerability on a 4-point scale | Up to 3 weeks after first drug administration |
| Investigator comparative overall assessment on a 4-point scale | After 3 weeks of first drug administration |
| Investigator assessment of efficacy on a 4-point scale | Up to 3 weeks after first drug administration |
| Number of patients who changed the concomitant medication | Up to 3 weeks after first drug administration |
| Number of patients who continued treatment | Up to 3 weeks after first drug administration |
| Number of patients who premature withdrew from the treatment | Up to 3 weeks after first drug administration |
| Number of patients with adverse drug reactions | Up to 3 weeks after first drug administration |
Outcome results
None listed