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

August 5, 2016 updated by: Rigel Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4M6
        • Centre De recherche Appliquee en Allergie DeQuebec
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Joseph Greenbaum, MD
      • Missassauga, Ontario, Canada, L5A 3V4
        • Cheema Research, Inc.
      • Niagara Falls, Ontario, Canada, L2G 1J4
        • Niagara Clinical Research
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Ottawa Allergy Research Corp
      • Toronto, Ontario, Canada, M6H 3M2
        • Primary Care Lung Clinic
      • Toronto, Ontario, Canada, M5G 1N8
        • Pulmonary Care Clinic
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Dynamik Research, Inc.
  • United States
    • California
      • Fullerton, California, United States, 92835
        • California Research Medical Group, Inc
      • Los Angeles, California, United States, 90048
        • Southern California Institute For Respiratory Diseases, Inc.
      • Los Angeles, California, United States, 90025
        • Allergy Medical Clinic Research Division
      • Los Angeles, California, United States, 90025
        • California Allergy & Asthma Medical Group, INC
      • Mission Viejo, California, United States, 92691
        • Allergy & Asthma Associates of Southern California
      • Orange, California, United States, 92868
        • CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group. Inc.
      • San Diego, California, United States, 92123
        • Allergy & Asthma Med Group/Research Center
      • San Jose, California, United States, 95117
        • Allergy & Asthma Associates of Santa Clara Valley
      • Stockton, California, United States, 95207
        • Bensch Research Associates
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Colorado Allergy and Asthma Clinic, PC
      • Colorado Springs, Colorado, United States, 80907
        • Asthma & Allergy Associates, PC
      • Denver, Colorado, United States, 80206
        • National Jewish Health
      • Denver, Colorado, United States, 80230
        • Colorado Allergy & Asthma Centers, PC
    • Florida
      • Aventura, Florida, United States, 33180
        • Florida Center for Allergy & Asthma Research
      • Melbourne, Florida, United States, 32935
        • Accelovance
      • Sarasota, Florida, United States, 34233
        • Sarasota Clinical Research
    • Georgia
      • Albany, Georgia, United States, 31707
        • Georgia Pollens Clinical Research Centers, Inc.
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Idaho Allergy DBA Idaho Research
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze & Itch Associates
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Chesapeake Clinical Research, Inc.
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc.
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Respiratory Medicine Researh Institute of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute, Inc.
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Clinical Research of The Ozarks, Inc.
      • St Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
    • Montana
      • Bozeman, Montana, United States, 59718
        • Clinical Research Group of Montana PLLC
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • The Asthma & Allergy Center
    • New Jersey
      • Ocean, New Jersey, United States, 07712
        • Atlantic Research Center, LLC
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research
      • Verona, New Jersey, United States, 07044
        • Allergy Consultants, PA
    • New York
      • New York, New York, United States, 10016
        • New York Pulmonary Associates, P.C.
      • Rochester, New York, United States, 14618
        • Allergy Asthma Immunology of Rochester (AAIR)
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma & Clinical Research Center
    • Oregon
      • Eugene, Oregon, United States, 97401-7721
        • Allergy & Asthma Research Group
      • Medford, Oregon, United States, 97504
        • Clinical Research Inst. of Southern Oregon, PC
      • Portland, Oregon, United States, 97202
        • Allergy Associates Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Allergy & Clinical Immunology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • National Allergy, Asthma and Uticaria Center of Charleston
    • Texas
      • Dallas, Texas, United States, 75231
        • Pharmaceutical Research & Consulting, Inc.
      • El Paso, Texas, United States, 79903
        • Western Sky Medical Research, Inc.
      • Live Oak, Texas, United States, 78233
        • Live Oak Allergy & Asthma Clinic
      • Waco, Texas, United States, 76712
        • Allergy Asthma Research Institute
      • Waco, Texas, United States, 76712
        • Allergy & Asthma Care of Waco, PA
    • Washington
      • Seattle, Washington, United States, 98115
        • ASTHMA, Inc.
      • Tacoma, Washington, United States, 98405
        • MultiCare Pulmonary Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical history of asthma
  • Ability to perform spirometry

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 puff bid or 2 puffs bid
Active Comparator: R940343 2mg, 2 puffs bid
R343 2mg, 2 puffs bid
Drug: R940343 2mg
R343 2mg, 2 puffs bid
Other Names:
  • R343
Active Comparator: R940343 1mg, 1 puff bid
R343 1mg, 1 puff bid
Drug: R940343 1mg
R343 1mg, 1 puff bid
Other Names:
  • R343

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FEV1
Time Frame: Baseline and Week 8
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigel Pharmaceuticals

Investigators

  • Study Director: Elliott Grossbard, MD, Rigel Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-940343-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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