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NCT01591044 Clinical Trial

A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma

Asthma Clinical Trial

— SITAR  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01591044
Other study ID # C-940343-004
Secondary ID
Status Completed
Phase Phase 2
First received April 30, 2012
Last updated August 12, 2013
Start date July 2012
Est. completion date July 2013

Study information
Verified date August 2013
Source Rigel Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

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 into 1 of 4 dosing groups

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Clinical history of asthma

- Ability to perform spirometry

Exclusion Criteria:

- Chronic obstructive pulmonary disease or bronchiectasis

- Upper or lower respiratory infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo x 1, 1 puff bid Placebo x 2, 2 puffs bid
• R940343
R343 1mg, 1 puff bid R343 2mg, 2 puffs bid

Locations
Country Name City State
Canada Joseph Greenbaum, MD Hamilton Ontario
Canada Cheema Research, Inc. Missassauga Ontario
Canada Niagara Clinical Research Niagara Falls Ontario
Canada Ottawa Allergy Research Corp Ottawa Ontario
Canada Dynamik Research, Inc. Pointe-Claire Quebec
Canada Centre De recherche Appliquee en Allergie DeQuebec Quebec
Canada Primary Care Lung Clinic Toronto Ontario
Canada Pulmonary Care Clinic Toronto Ontario
United States Georgia Pollens Clinical Research Centers, Inc. Albany Georgia
United States Florida Center for Allergy & Asthma Research Aventura Florida
United States Chesapeake Clinical Research, Inc. Baltimore Maryland
United States The Asthma & Allergy Center Bellevue Nebraska
United States Clinical Research Group of Montana PLLC Bozeman Montana
United States Colorado Allergy and Asthma Clinic, PC Centennial Colorado
United States National Allergy, Asthma and Uticaria Center of Charleston Charleston South Carolina
United States New Horizons Clinical Research Cincinnati Ohio
United States Asthma & Allergy Associates, PC Colorado Springs Colorado
United States Clinical Research of The Ozarks, Inc. Columbia Missouri
United States Pharmaceutical Research & Consulting, Inc. Dallas Texas
United States Colorado Allergy & Asthma Centers, PC Denver Colorado
United States National Jewish Health Denver Colorado
United States Idaho Allergy DBA Idaho Research Eagle Idaho
United States Western Sky Medical Research, Inc. El Paso Texas
United States Allergy & Asthma Research Group Eugene Oregon
United States California Research Medical Group, Inc Fullerton California
United States Peters Medical Research High Point North Carolina
United States Live Oak Allergy & Asthma Clinic Live Oak Texas
United States Allergy Medical Clinic Research Division Los Angeles California
United States California Allergy & Asthma Medical Group, INC Los Angeles California
United States Southern California Institute for Respiratory Diseases, Inc. Los Angeles California
United States Clinical Research Inst. of Southern Oregon, PC Medford Oregon
United States Accelovance Melbourne Florida
United States Clinical Research Institute Minneapolis Minnesota
United States Allergy & Asthma Associates of Southern California Mission Viejo California
United States New York Pulmonary Associates, P.C. New York New York
United States Sneeze, Wheeze & Itch Associates Normal Illinois
United States Northeast Medical Research Associates, Inc. North Dartmouth Massachusetts
United States Atlantic Research Center, LLC Ocean New Jersey
United States Allergy, Asthma & Clinical Research Center Oklahoma City Oklahoma
United States CHOC PSF, AMC, Division of Allergy, Asthma & Immunology Orange California
United States Allergy & Clinical Immunology Associates Pittsburgh Pennsylvania
United States Clinical Research Institute, Inc. Plymouth Minnesota
United States Allergy Associates Research Center Portland Oregon
United States North Carolina Clinical Research Raleigh North Carolina
United States Allergy Asthma Immunology of Rochester (AAIR) Rochester New York
United States Peninsula Research Associates Rolling Hills Estates California
United States Allergy & Asthma Med Group/Research Center San Diego California
United States Allergy Associates Medical Group. Inc. San Diego California
United States Allergy & Asthma Associates of Santa Clara Valley San Jose California
United States Sarasota Clinical Research Sarasota Florida
United States ASTHMA, Inc. Seattle Washington
United States Princeton Center for Clinical Research Skillman New Jersey
United States The Clinical Research Center, LLC St Louis Missouri
United States Bensch Research Associates Stockton California
United States MultiCare Pulmonary Specialists Tacoma Washington
United States Allergy Consultants, PA Verona New Jersey
United States Allergy & Asthma Care of Waco, PA Waco Texas
United States Allergy Asthma Research Institute Waco Texas
United States Respiratory Medicine Researh Institute of Michigan Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Rigel Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in FEV1 Baseline and Week 8 Yes
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