A Study of ARRY-502 in Patients With Persistent Asthma
- Conditions
- Asthma
- Interventions
- Drug: Placebo; oralDrug: ARRY-502, CRTh2 antagonist; oral
- Registration Number
- NCT01561690
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the US will be enrolled in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- Documented history of bronchial asthma diagnosed at least 6 months prior to study start and prior to the age of 40 years.
- Body mass index (BMI) of 18 to 35 inclusive.
- An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug.
- A best prebronchodilator FEV1 of 60% to 85% of the predicted normal value and a change in best postbronchodilator FEV1 of ≥ 12% and ≥ 200 mL at specified time points prior to first dose of study drug.
- Additional criteria exist.
Key
- Evidence of aspirin-sensitive asthma.
- Pre-existing lung disease other than asthma.
- Clinically significant dermatologic, hematological, renal, endocrine, pulmonary (other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease and asthma) that is uncontrolled despite treatment or is likely in the opinion of the Investigator to require a change in therapy during the study.
- Patients with any current or past history of cancer within 5 years prior to study start except for treated basal cell or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or cervical carcinomas in situ.
- Any history of serious illness requiring hospitalization within 6 months prior to study start.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
- A positive test for drugs or alcohol, unless the positive drug screen is associated with a prescribed medication and is approved by the Medical Monitor.
- Smoking (tobacco or marijuana) within 6 months prior to study start and/or a smoking history of > 10 packs/year.
- Blood donation of ≥ 1 pint (473 mL) within 8 weeks prior to the first dose of study drug.
- Previous treatment with ARRY-502.
- Additional criteria exist.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo; oral - ARRY-502 ARRY-502, CRTh2 antagonist; oral -
- Primary Outcome Measures
Name Time Method Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1). 6 weeks
- Secondary Outcome Measures
Name Time Method Measure the exposure of study drug in terms of plasma concentrations. 6 weeks Assess the effect of study drug on respiratory function in terms of FEV1, forced vital capacity (FVC), forced expiratory flow (FEF) and peak expiratory flow (PEF). 6 weeks Assess the effect of study drug on asthma control in terms of Asthma Control Questionnaire (ACQ) score, the number of symptom-free days and the number of weekly short-acting beta (ß) 2 agonist (SABA) metered dose inhaler (MDI) actuations. 6 weeks Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. 6 weeks
Trial Locations
- Locations (42)
Allergy Medical Clinic - Research Division
🇺🇸Los Angeles, California, United States
Chesapeake Clinical Research Inc
🇺🇸Baltimore, Maryland, United States
Asthma Inc.
🇺🇸Seattle, Washington, United States
South Florida Research Trials
🇺🇸Miami, Florida, United States
Allergy Associates Medical Group
🇺🇸San Diego, California, United States
Western Sky Medical Research Inc
🇺🇸El Paso, Texas, United States
Colorado Allergy and Asthma Center
🇺🇸Centennial, Colorado, United States
Asthma & Allergy Associates PC
🇺🇸Colorado Springs, Colorado, United States
Rocky Mountain Center for Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Allergy Asthma & Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Pulmonary Disease Specialists
🇺🇸Kissimmee, Florida, United States
Asthma Allergy & Pulmonary Research
🇺🇸Madison, Wisconsin, United States
Idaho Research
🇺🇸Eagle, Idaho, United States
Clinical Research Institute of Southern Oregon
🇺🇸Medford, Oregon, United States
Northeast Medical Research Associates
🇺🇸North Dartmouth, Massachusetts, United States
Allergy & Asthma Diagnostic Treatment Center
🇺🇸Tallahassee, Florida, United States
Allergy Asthma & Sinus Center, S.C.
🇺🇸Greenfield, Wisconsin, United States
Florida Pulmonary Research Institute
🇺🇸Winter Park, Florida, United States
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
The Asthma & Allergy Center
🇺🇸Bellevue, Nebraska, United States
Baker Allergy, Asthma & Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
Clinical Research Group of Montana
🇺🇸Bozeman, Montana, United States
Allergy & Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
California Allergy & Asthma Med. Group
🇺🇸Los Angeles, California, United States
Southern California Institute for Respiratory Diseases Inc
🇺🇸Los Angeles, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Clinical Neuroscience Solutions
🇺🇸Jacksonville, Florida, United States
Sneeze, Wheeze & Itch
🇺🇸Normal, Illinois, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
Bernstein Clinical Research
🇺🇸Cincinnati, Ohio, United States
Allergy, Respiratory & Sleep Center
🇺🇸Canton, Ohio, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
Vital Prospects Clinical Research Institute, PC
🇺🇸Tulsa, Oklahoma, United States
University of Pittsburgh Asthma Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Tekton Research
🇺🇸Austin, Texas, United States
Pharmaceutical Research & Consulting Inc.
🇺🇸Dallas, Texas, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
IMMUNOe International Research Centers
🇺🇸Centennial, Colorado, United States