A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
SITAR
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
1 other identifier
interventional
301
2 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jul 2012
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
September 29, 2016
CompletedSeptember 29, 2016
August 1, 2016
1 year
April 30, 2012
May 17, 2016
August 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in FEV1
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Baseline and Week 8
Study Arms (3)
R940343 2mg, 2 puffs bid
ACTIVE COMPARATORR343 2mg, 2 puffs bid
Placebo
PLACEBO COMPARATORR940343 1mg, 1 puff bid
ACTIVE COMPARATORR343 1mg, 1 puff bid
Interventions
Eligibility Criteria
You may qualify if:
- Clinical history of asthma
- Ability to perform spirometry
You may not qualify if:
- Chronic obstructive pulmonary disease or bronchiectasis
- Upper or lower respiratory infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
California Research Medical Group, Inc
Fullerton, California, 92835, United States
Allergy Medical Clinic Research Division
Los Angeles, California, 90025, United States
California Allergy & Asthma Medical Group, INC
Los Angeles, California, 90025, United States
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, 90048, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691, United States
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
Orange, California, 92868, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Allergy Associates Medical Group. Inc.
San Diego, California, 92120, United States
Allergy & Asthma Med Group/Research Center
San Diego, California, 92123, United States
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, 95117, United States
Bensch Research Associates
Stockton, California, 95207, United States
Colorado Allergy and Asthma Clinic, PC
Centennial, Colorado, 80112, United States
Asthma & Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
National Jewish Health
Denver, Colorado, 80206, United States
Colorado Allergy & Asthma Centers, PC
Denver, Colorado, 80230, United States
Florida Center for Allergy & Asthma Research
Aventura, Florida, 33180, United States
Accelovance
Melbourne, Florida, 32935, United States
Sarasota Clinical Research
Sarasota, Florida, 34233, United States
Georgia Pollens Clinical Research Centers, Inc.
Albany, Georgia, 31707, United States
Idaho Allergy DBA Idaho Research
Eagle, Idaho, 83616, United States
Sneeze, Wheeze & Itch Associates
Normal, Illinois, 61761, United States
Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747, United States
Respiratory Medicine Researh Institute of Michigan
Ypsilanti, Michigan, 48197, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota, 55441, United States
Clinical Research of The Ozarks, Inc.
Columbia, Missouri, 65203, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
Clinical Research Group of Montana PLLC
Bozeman, Montana, 59718, United States
The Asthma & Allergy Center
Bellevue, Nebraska, 68123, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Allergy Consultants, PA
Verona, New Jersey, 07044, United States
New York Pulmonary Associates, P.C.
New York, New York, 10016, United States
Allergy Asthma Immunology of Rochester (AAIR)
Rochester, New York, 14618, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Allergy & Asthma Research Group
Eugene, Oregon, 97401-7721, United States
Clinical Research Inst. of Southern Oregon, PC
Medford, Oregon, 97504, United States
Allergy Associates Research Center
Portland, Oregon, 97202, United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
National Allergy, Asthma and Uticaria Center of Charleston
Charleston, South Carolina, 29406, United States
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231, United States
Western Sky Medical Research, Inc.
El Paso, Texas, 79903, United States
Live Oak Allergy & Asthma Clinic
Live Oak, Texas, 78233, United States
Allergy & Asthma Care of Waco, PA
Waco, Texas, 76712, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, United States
ASTHMA, Inc.
Seattle, Washington, 98115, United States
MultiCare Pulmonary Specialists
Tacoma, Washington, 98405, United States
Joseph Greenbaum, MD
Hamilton, Ontario, L8N 1Y2, Canada
Cheema Research, Inc.
Missassauga, Ontario, L5A 3V4, Canada
Niagara Clinical Research
Niagara Falls, Ontario, L2G 1J4, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, K1Y 4G2, Canada
Pulmonary Care Clinic
Toronto, Ontario, M5G 1N8, Canada
Primary Care Lung Clinic
Toronto, Ontario, M6H 3M2, Canada
Dynamik Research, Inc.
Pointe-Claire, Quebec, H9R 3J1, Canada
Centre De recherche Appliquee en Allergie DeQuebec
Québec, Quebec, G1V 4M6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne-Marie Duliege, MD
- Organization
- Rigel
Study Officials
- STUDY DIRECTOR
Elliott Grossbard, MD
Rigel Pharmaceuticals,Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 3, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
September 29, 2016
Results First Posted
September 29, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share