The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00076076
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 822
Inclusion Criteria
- Diagnosis of persistent chronic bronchial asthma
- Baseline lung function within specified parameters
- No change in asthma treatment during the last 4 weeks prior to start of baseline period
- Stable clinical state
- Except for asthma, in good health
- Non-smokers or ex-smokers
Main
Exclusion Criteria
- Poorly controlled asthma
- Diagnosis of chronic pulmonary disease and/or other relevant lung diseases
- Patients using continuously (more than 3 days per week) > 8 puffs/day rescue medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change in lung function.
- Secondary Outcome Measures
Name Time Method change in morning PEF asthma symptom score rescue medication time to withdrawal due to worsening asthma.
Trial Locations
- Locations (1)
ALTANA Pharma
🇺🇦Cities in the Ukraine, Ukraine