The purpose of this study is to determine whether roflumilast is effective in the treatment of asthma.
Official Title
FLASH Study: A 24 week randomized, controlled study of roflumilast versus placebo in patients with asthma
Conditions
Asthma
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Details
Study Start
Study start: October 2003; Expected completion: July 2004
Eligibility & Criteria
Inclusion criteria- diagnosis of persistent chronic bronchial asthma – baseline FEV1 % predicted between: 45 – 85% in patients either untreated or treated with asthma medication (except inhaled corticosteroids); 60-90% in patients receiving less than or equal to 840 mcg/day beclamethasone dipropionate – chlorofluorocarbons(BDP-CFC) ex mouthpiece or equivalent alone or in combination with any other asthma medication – 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 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 – Additional inclusion/exclusion criteria also apply, and examination by an investigator is required to determine eligibility
Total Enrolment
822
Contact Details
Dawn VanderMay 973-514-4275 dawn.vandermay@altanapharma-us.comPfizer Inofrmation Center
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