Clinical trial NCT01591044: A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Doses of Inhaled R940343 in Patients With Mild to Moderate Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 301
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: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical history of asthma
* Ability to perform spirometry

Exclusion Criteria:

* Chronic obstructive pulmonary disease or bronchiectasis
* Upper or lower respiratory infection

Primary outcomes:
measure: Change in FEV1
timeFrame: Baseline and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: California Research Medical Group, Inc
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 Medical Group, INC
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: Allergy & Asthma Associates of Southern California
state: California
city: Orange
country: United States
facility: CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
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. Inc.
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Med Group/Research Center
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Centennial
country: United States
facility: Colorado Allergy and Asthma Clinic, PC
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates, PC
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy & Asthma Centers, PC
state: Colorado
city: Aventura
country: United States
facility: Florida Center for Allergy & Asthma Research
state: Florida
city: Melbourne
country: United States
facility: Accelovance
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc.
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy DBA Idaho Research
state: Idaho
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates
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, Inc.
state: Massachusetts
city: Ypsilanti
country: United States
facility: Respiratory Medicine Researh Institute of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Columbia
country: United States
facility: Clinical Research of The Ozarks, Inc.
state: Missouri
city: St Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Bozeman
country: United States
facility: Clinical Research Group of Montana PLLC
state: Montana
city: Bellevue
country: United States
facility: The Asthma & Allergy Center
state: Nebraska
city: Ocean
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Verona
country: United States
facility: Allergy Consultants, PA
state: New Jersey
city: New York
country: United States
facility: New York Pulmonary Associates, P.C.
state: New York
city: Rochester
country: United States
facility: Allergy Asthma Immunology of Rochester (AAIR)
state: New York
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Eugene
country: United States
facility: Allergy & Asthma Research Group
state: Oregon
city: Medford
country: United States
facility: Clinical Research Inst. of Southern Oregon, PC
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immunology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy, Asthma and Uticaria Center of Charleston
state: South Carolina
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: Live Oak
country: United States
facility: Live Oak Allergy & Asthma Clinic
state: Texas
city: Waco
country: United States
facility: Allergy & Asthma Care of Waco, PA
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Seattle
country: United States
facility: ASTHMA, Inc.
state: Washington
city: Tacoma
country: United States
facility: MultiCare Pulmonary Specialists
state: Washington
city: Hamilton
country: Canada
facility: Joseph Greenbaum, MD
state: Ontario
city: Missassauga
country: Canada
facility: Cheema Research, Inc.
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Clinical Research
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corp
state: Ontario
city: Toronto
country: Canada
facility: Pulmonary Care Clinic
state: Ontario
city: Toronto
country: Canada
facility: Primary Care Lung Clinic
state: Ontario
city: Pointe-Claire
country: Canada
facility: Dynamik Research, Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre De recherche Appliquee en Allergie DeQuebec
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Elliott Grossbard, MD
role: STUDY_DIRECTOR
References: