The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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