The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)
Status and phase
Completed
Phase 3
Conditions
Asthma
Treatments
Drug: Roflumilast
Details and patient eligibility
About
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.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Main 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
41
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Data sourced from clinicaltrials.gov
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