The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.
The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
301
1 puff bid or 2 puffs bid
R343 1mg, 1 puff bid
R343 2mg, 2 puffs bid
Change in FEV1
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Time frame: Baseline and Week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
California Research Medical Group, Inc
Fullerton, California, United States
Allergy Medical Clinic Research Division
Los Angeles, California, United States
California Allergy & Asthma Medical Group, INC
Los Angeles, California, United States
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
Orange, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Allergy Associates Medical Group. Inc.
San Diego, California, United States
Allergy & Asthma Med Group/Research Center
San Diego, California, United States
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, United States
...and 49 more locations