A Study of ARRY-502 in Patients With Persistent Asthma
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of ARRY-502 in Adults With Persistent Asthma
2 other identifiers
interventional
184
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Apr 2012
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedStudy Start
First participant enrolled
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2013
CompletedOctober 30, 2023
October 1, 2023
1.2 years
March 21, 2012
October 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).
6 weeks
Secondary Outcomes (4)
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
6 weeks
Measure the exposure of study drug in terms of plasma concentrations.
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 (ĂŸ) 2 agonist (SABA) metered dose inhaler (MDI) actuations.
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
Study Arms (2)
ARRY-502
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (43)
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647, United States
Allergy Medical Clinic - Research Division
Los Angeles, California, 90025, United States
California Allergy & Asthma Med. Group
Los Angeles, California, 90025, United States
Southern California Institute for Respiratory Diseases Inc
Los Angeles, California, 90048, United States
Southern California Research
Mission Viejo, California, 92691, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Allergy Associates Medical Group
San Diego, California, 92120, United States
Colorado Allergy and Asthma Center
Centennial, Colorado, 80112, United States
IMMUNOe International Research Centers
Centennial, Colorado, 80112, United States
Asthma & Allergy Associates PC
Colorado Springs, Colorado, 80909, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256, United States
Pulmonary Disease Specialists
Kissimmee, Florida, 34741, United States
South Florida Research Trials
Miami, Florida, 33186, United States
Allergy & Asthma Diagnostic Treatment Center
Tallahassee, Florida, 32308, United States
Florida Pulmonary Research Institute
Winter Park, Florida, 32789, United States
Idaho Research
Eagle, Idaho, 83616, United States
Sneeze, Wheeze & Itch
Normal, Illinois, 61761, United States
Chesapeake Clinical Research Inc
Baltimore, Maryland, 21236, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
Clinical Research Group of Montana
Bozeman, Montana, 59718, United States
The Asthma & Allergy Center
Bellevue, Nebraska, 68123, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Allergy, Respiratory & Sleep Center
Canton, Ohio, 44718, United States
Bernstein Clinical Research
Cincinnati, Ohio, 45231, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Allergy Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136, United States
Baker Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504, United States
University of Pittsburgh Asthma Institute
Pittsburgh, Pennsylvania, 15213, United States
Tekton Research
Austin, Texas, 78745, United States
Pharmaceutical Research & Consulting Inc.
Dallas, Texas, 75231, United States
Western Sky Medical Research Inc
El Paso, Texas, 79903, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Asthma Inc.
Seattle, Washington, 98105, United States
Allergy Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228, United States
Asthma Allergy & Pulmonary Research
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
March 23, 2012
Study Start
April 2, 2012
Primary Completion
May 31, 2013
Study Completion
June 10, 2013
Last Updated
October 30, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.