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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591044
First Posted: May 3, 2012
Last Update Posted: September 29, 2016
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.
Information provided by (Responsible Party):
Rigel Pharmaceuticals
  Purpose
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

Condition Intervention Phase
Asthma Drug: Placebo Drug: R940343 1mg Drug: R940343 2mg Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rigel Pharmaceuticals:

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


Enrollment: 301
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Clinical history of asthma
  • Ability to perform spirometry

Exclusion Criteria:

  • Chronic obstructive pulmonary disease or bronchiectasis
  • Upper or lower respiratory infection
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01591044


  Show 59 Study Locations
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Study Director: Elliott Grossbard, MD Rigel Pharmaceuticals, Inc.
  More Information

Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01591044     History of Changes
Other Study ID Numbers: C-940343-004
First Submitted: April 30, 2012
First Posted: May 3, 2012
Results First Submitted: May 17, 2016
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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases