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FLASH Study: A study of roflumilast versus placebo in patients with asthma



FLASH Study: A study of roflumilast versus placebo in patients with asthma

For Condition: Asthma
Status: Recruiting
Sponsor(s): ALTANA Pharma , Pfizer
Synopsis: The purpose of this study is to determine whether roflumilast is effective in the treatment of asthma.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 Enrollment: 822

Location and Contact Information:

Gordon Raphael, M.D. *Recruiting*
Bethesda,  Maryland,  20814
United States
Recruiting Mindy  Raphael 301-907-3476


Additional Information:
Study ID Numbers:  BY217/M2-023; 
Study Start Date: October 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076076

Other Asthma Studies:
1. The efficacy and safety of omalizumab in patients with severe persistent asthma

2. Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (test drug) in Moderate Persistent Asthma

3. Modification of Allergic Immunologic Response by Leukotriene Antagonists - Ancillary to ACRN IMPACT

4. The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma

5. Community Organizing Network for Environmental Health

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