A Study of ARRY-502 in Patients With Persistent Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561690
• Other study ID #: ARRAY-502-201
• Secondary ID: C4681001
• Status: Completed
• Phase: Phase 2
• Start date: April 2, 2012
• Est. completion date: June 10, 2013

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 10, 2013
• Est. primary completion date: May 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ARRY-502, CRTh2 antagonist; oral
multiple dose, single schedule
• Placebo; oral
matching placebo

Locations

Country	Name	City	State
United States	Tekton Research	Austin	Texas
United States	Chesapeake Clinical Research Inc	Baltimore	Maryland
United States	The Asthma & Allergy Center	Bellevue	Nebraska
United States	Clinical Research Group of Montana	Bozeman	Montana
United States	Allergy, Respiratory & Sleep Center	Canton	Ohio
United States	Colorado Allergy and Asthma Center	Centennial	Colorado
United States	IMMUNOe International Research Centers	Centennial	Colorado
United States	Bernstein Clinical Research	Cincinnati	Ohio
United States	Asthma & Allergy Associates PC	Colorado Springs	Colorado
United States	Pharmaceutical Research & Consulting Inc.	Dallas	Texas
United States	Idaho Research	Eagle	Idaho
United States	Western Sky Medical Research Inc	El Paso	Texas
United States	Allergy Asthma & Sinus Center, S.C.	Greenfield	Wisconsin
United States	Allergy & Asthma Specialists Medical Group	Huntington Beach	California
United States	Clinical Neuroscience Solutions	Jacksonville	Florida
United States	Pulmonary Disease Specialists	Kissimmee	Florida
United States	Baker Allergy, Asthma & Dermatology Research Center	Lake Oswego	Oregon
United States	Allergy Medical Clinic - Research Division	Los Angeles	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	Asthma Allergy & Pulmonary Research	Madison	Wisconsin
United States	Clinical Research Institute of Southern Oregon	Medford	Oregon
United States	South Florida Research Trials	Miami	Florida
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Southern California Research	Mission Viejo	California
United States	Central Texas Health Research	New Braunfels	Texas
United States	Sneeze, Wheeze & Itch	Normal	Illinois
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts
United States	Allergy Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	University of Pittsburgh Asthma Institute	Pittsburgh	Pennsylvania
United States	Clinical Research Institute	Plymouth	Minnesota
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy Associates Medical Group	San Diego	California
United States	Asthma Inc.	Seattle	Washington
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Allergy & Asthma Diagnostic Treatment Center	Tallahassee	Florida
United States	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma
United States	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado
United States	Florida Pulmonary Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).		6 weeks
Secondary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.		6 weeks
Secondary	Measure the exposure of study drug in terms of plasma concentrations.		6 weeks
Secondary	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
Secondary	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