A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
- Conditions
- Asthma
- Interventions
- Drug: R940343 1mgDrug: R940343 2mgDrug: Placebo
- Registration Number
- NCT01591044
- Lead Sponsor
- Rigel Pharmaceuticals
- Brief Summary
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
- Clinical history of asthma
- Ability to perform spirometry
- Chronic obstructive pulmonary disease or bronchiectasis
- Upper or lower respiratory infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R940343 1mg, 1 puff bid R940343 1mg R343 1mg, 1 puff bid R940343 2mg, 2 puffs bid R940343 2mg R343 2mg, 2 puffs bid Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in FEV1 Baseline and Week 8 Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Allergy Consultants, PA
🇺🇸Verona, New Jersey, United States
The Asthma & Allergy Center
🇺🇸Bellevue, Nebraska, United States
National Allergy, Asthma and Uticaria Center of Charleston
🇺🇸Charleston, South Carolina, United States
Allergy Medical Clinic Research Division
🇺🇸Los Angeles, California, United States
California Research Medical Group, Inc
🇺🇸Fullerton, California, United States
Southern California Institute for Respiratory Diseases, Inc.
🇺🇸Los Angeles, California, United States
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
🇺🇸Orange, California, United States
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Allergy & Asthma Associates of Santa Clara Valley
🇺🇸San Jose, California, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Colorado Allergy and Asthma Clinic, PC
🇺🇸Centennial, Colorado, United States
Asthma & Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Chesapeake Clinical Research, Inc.
🇺🇸Baltimore, Maryland, United States
Florida Center for Allergy & Asthma Research
🇺🇸Aventura, Florida, United States
Accelovance
🇺🇸Melbourne, Florida, United States
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
Sneeze, Wheeze & Itch Associates
🇺🇸Normal, Illinois, United States
Georgia Pollens Clinical Research Centers, Inc.
🇺🇸Albany, Georgia, United States
Idaho Allergy DBA Idaho Research
🇺🇸Eagle, Idaho, United States
Northeast Medical Research Associates, Inc.
🇺🇸North Dartmouth, Massachusetts, United States
Respiratory Medicine Researh Institute of Michigan
🇺🇸Ypsilanti, Michigan, United States
The Clinical Research Center, LLC
🇺🇸St Louis, Missouri, United States
Clinical Research Institute, Inc.
🇺🇸Plymouth, Minnesota, United States
Clinical Research of The Ozarks, Inc.
🇺🇸Columbia, Missouri, United States
Clinical Research Group of Montana PLLC
🇺🇸Bozeman, Montana, United States
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
Atlantic Research Center, LLC
🇺🇸Ocean, New Jersey, United States
Allergy Asthma Immunology of Rochester (AAIR)
🇺🇸Rochester, New York, United States
New York Pulmonary Associates, P.C.
🇺🇸New York, New York, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Clinical Research Inst. of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Allergy & Asthma Research Group
🇺🇸Eugene, Oregon, United States
Allergy & Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Pharmaceutical Research & Consulting, Inc.
🇺🇸Dallas, Texas, United States
ASTHMA, Inc.
🇺🇸Seattle, Washington, United States
Western Sky Medical Research, Inc.
🇺🇸El Paso, Texas, United States
Allergy & Asthma Care of Waco, PA
🇺🇸Waco, Texas, United States
Live Oak Allergy & Asthma Clinic
🇺🇸Live Oak, Texas, United States
MultiCare Pulmonary Specialists
🇺🇸Tacoma, Washington, United States
Dynamik Research, Inc.
🇨🇦Pointe-Claire, Quebec, Canada
Niagara Clinical Research
🇨🇦Niagara Falls, Ontario, Canada
Pulmonary Care Clinic
🇨🇦Toronto, Ontario, Canada
Ottawa Allergy Research Corp
🇨🇦Ottawa, Ontario, Canada
Joseph Greenbaum, MD
🇨🇦Hamilton, Ontario, Canada
Cheema Research, Inc.
🇨🇦Missassauga, Ontario, Canada
Primary Care Lung Clinic
🇨🇦Toronto, Ontario, Canada
Centre De recherche Appliquee en Allergie DeQuebec
🇨🇦Quebec, Canada
California Allergy & Asthma Medical Group, INC
🇺🇸Los Angeles, California, United States
Allergy Associates Medical Group. Inc.
🇺🇸San Diego, California, United States
Allergy & Asthma Med Group/Research Center
🇺🇸San Diego, California, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Colorado Allergy & Asthma Centers, PC
🇺🇸Denver, Colorado, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Allergy, Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States