search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
R940343 1mg
R940343 2mg
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical history of asthma
  • Ability to perform spirometry

Exclusion Criteria:

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

Sites / Locations

  • California Research Medical Group, Inc
  • Allergy Medical Clinic Research Division
  • California Allergy & Asthma Medical Group, INC
  • Southern California Institute for Respiratory Diseases, Inc.
  • Allergy & Asthma Associates of Southern California
  • CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
  • Peninsula Research Associates
  • Allergy Associates Medical Group. Inc.
  • Allergy & Asthma Med Group/Research Center
  • Allergy & Asthma Associates of Santa Clara Valley
  • Bensch Research Associates
  • Colorado Allergy and Asthma Clinic, PC
  • Asthma & Allergy Associates, PC
  • National Jewish Health
  • Colorado Allergy & Asthma Centers, PC
  • Florida Center for Allergy & Asthma Research
  • Accelovance
  • Sarasota Clinical Research
  • Georgia Pollens Clinical Research Centers, Inc.
  • Idaho Allergy DBA Idaho Research
  • Sneeze, Wheeze & Itch Associates
  • Chesapeake Clinical Research, Inc.
  • Northeast Medical Research Associates, Inc.
  • Respiratory Medicine Researh Institute of Michigan
  • Clinical Research Institute
  • Clinical Research Institute, Inc.
  • Clinical Research of The Ozarks, Inc.
  • The Clinical Research Center, LLC
  • Clinical Research Group of Montana PLLC
  • The Asthma & Allergy Center
  • Atlantic Research Center, LLC
  • Princeton Center for Clinical Research
  • Allergy Consultants, PA
  • New York Pulmonary Associates, P.C.
  • Allergy Asthma Immunology of Rochester (AAIR)
  • Peters Medical Research
  • North Carolina Clinical Research
  • New Horizons Clinical Research
  • Allergy, Asthma & Clinical Research Center
  • Allergy & Asthma Research Group
  • Clinical Research Inst. of Southern Oregon, PC
  • Allergy Associates Research Center
  • Allergy & Clinical Immunology Associates
  • National Allergy, Asthma and Uticaria Center of Charleston
  • Pharmaceutical Research & Consulting, Inc.
  • Western Sky Medical Research, Inc.
  • Live Oak Allergy & Asthma Clinic
  • Allergy & Asthma Care of Waco, PA
  • Allergy Asthma Research Institute
  • ASTHMA, Inc.
  • MultiCare Pulmonary Specialists
  • Joseph Greenbaum, MD
  • Cheema Research, Inc.
  • Niagara Clinical Research
  • Ottawa Allergy Research Corp
  • Pulmonary Care Clinic
  • Primary Care Lung Clinic
  • Dynamik Research, Inc.
  • Centre De recherche Appliquee en Allergie DeQuebec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

R940343 2mg, 2 puffs bid

Placebo

R940343 1mg, 1 puff bid

Arm Description

R343 2mg, 2 puffs bid

R343 1mg, 1 puff bid

Outcomes

Primary Outcome Measures

Change in FEV1
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2012
Last Updated
August 5, 2016
Sponsor
Rigel Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01591044
Brief Title
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R940343 2mg, 2 puffs bid
Arm Type
Active Comparator
Arm Description
R343 2mg, 2 puffs bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
R940343 1mg, 1 puff bid
Arm Type
Active Comparator
Arm Description
R343 1mg, 1 puff bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 puff bid or 2 puffs bid
Intervention Type
Drug
Intervention Name(s)
R940343 1mg
Other Intervention Name(s)
R343
Intervention Description
R343 1mg, 1 puff bid
Intervention Type
Drug
Intervention Name(s)
R940343 2mg
Other Intervention Name(s)
R343
Intervention Description
R343 2mg, 2 puffs bid
Primary Outcome Measure Information:
Title
Change in FEV1
Description
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Time Frame
Baseline and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Grossbard, MD
Organizational Affiliation
Rigel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
California Research Medical Group, Inc
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Allergy Medical Clinic Research Division
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
California Allergy & Asthma Medical Group, INC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Institute for Respiratory Diseases, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
CHOC PSF, AMC, Division of Allergy, Asthma & Immunology
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy Associates Medical Group. Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Allergy & Asthma Med Group/Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Valley
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Bensch Research Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Colorado Allergy and Asthma Clinic, PC
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Asthma & Allergy Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Colorado Allergy & Asthma Centers, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Florida Center for Allergy & Asthma Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Accelovance
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Sarasota Clinical Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Georgia Pollens Clinical Research Centers, Inc.
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Idaho Allergy DBA Idaho Research
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Sneeze, Wheeze & Itch Associates
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Chesapeake Clinical Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Northeast Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Respiratory Medicine Researh Institute of Michigan
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Clinical Research of The Ozarks, Inc.
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
The Clinical Research Center, LLC
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Group of Montana PLLC
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
The Asthma & Allergy Center
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Atlantic Research Center, LLC
City
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Allergy Consultants, PA
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
New York Pulmonary Associates, P.C.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Allergy Asthma Immunology of Rochester (AAIR)
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Allergy, Asthma & Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Allergy & Asthma Research Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-7721
Country
United States
Facility Name
Clinical Research Inst. of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy Associates Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Allergy & Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
National Allergy, Asthma and Uticaria Center of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Pharmaceutical Research & Consulting, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Western Sky Medical Research, Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Live Oak Allergy & Asthma Clinic
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Allergy & Asthma Care of Waco, PA
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
ASTHMA, Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
MultiCare Pulmonary Specialists
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Joseph Greenbaum, MD
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Cheema Research, Inc.
City
Missassauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
Niagara Clinical Research
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2G 1J4
Country
Canada
Facility Name
Ottawa Allergy Research Corp
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Pulmonary Care Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Facility Name
Primary Care Lung Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M2
Country
Canada
Facility Name
Dynamik Research, Inc.
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Centre De recherche Appliquee en Allergie DeQuebec
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs