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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01591044
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):
Rigel Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Placebo Drug: R940343 1mg Drug: R940343 2mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: R940343 2mg, 2 puffs bid
R343 2mg, 2 puffs bid
Drug: R940343 2mg
R343 2mg, 2 puffs bid
Other Name: R343

Placebo Comparator: Placebo Drug: Placebo
1 puff bid or 2 puffs bid

Active Comparator: R940343 1mg, 1 puff bid
R343 1mg, 1 puff bid
Drug: R940343 1mg
R343 1mg, 1 puff bid
Other Name: R343

Primary Outcome Measures :
  1. Change in FEV1 [ Time Frame: Baseline and Week 8 ]
    Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical history of asthma
  • Ability to perform spirometry

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01591044

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Sponsors and Collaborators
Rigel Pharmaceuticals
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Study Director: Elliott Grossbard, MD Rigel Pharmaceuticals, Inc.

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Responsible Party: Rigel Pharmaceuticals Identifier: NCT01591044     History of Changes
Other Study ID Numbers: C-940343-004
First Posted: May 3, 2012    Key Record Dates
Results First Posted: September 29, 2016
Last Update Posted: September 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases