Clinical trial NCT01561690: A Study of ARRY-502 in Patients With Persistent Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).
timeFrame: 6 weeks
Secondary outcomes:
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
timeFrame: 6 weeks
measure: Measure the exposure of study drug in terms of plasma concentrations.
timeFrame: 6 weeks
measure: 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.
timeFrame: 6 weeks
measure: 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).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Allergy & Asthma Specialists Medical Group
state: California
city: Los Angeles
country: United States
facility: Allergy Medical Clinic - Research Division
state: California
city: Los Angeles
country: United States
facility: California Allergy & Asthma Med. Group
state: California
city: Los Angeles
country: United States
facility: Southern California Institute for Respiratory Diseases Inc
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: Centennial
country: United States
facility: Colorado Allergy and Asthma Center
state: Colorado
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates PC
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialists
state: Florida
city: Miami
country: United States
facility: South Florida Research Trials
state: Florida
city: Tallahassee
country: United States
facility: Allergy & Asthma Diagnostic Treatment Center
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute
state: Florida
city: Eagle
country: United States
facility: Idaho Research
state: Idaho
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch
state: Illinois
city: Baltimore
country: United States
facility: Chesapeake Clinical Research Inc
state: Maryland
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Bozeman
country: United States
facility: Clinical Research Group of Montana
state: Montana
city: Bellevue
country: United States
facility: The Asthma & Allergy Center
state: Nebraska
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Canton
country: United States
facility: Allergy, Respiratory & Sleep Center
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research
state: Ohio
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Allergy Asthma & Clinical Research Center
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma & Dermatology Research Center
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Asthma Institute
state: Pennsylvania
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting Inc.
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research Inc
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Seattle
country: United States
facility: Asthma Inc.
state: Washington
city: Greenfield
country: United States
facility: Allergy Asthma & Sinus Center, S.C.
state: Wisconsin
city: Madison
country: United States
facility: Asthma Allergy & Pulmonary Research
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: