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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01591044
First received: April 30, 2012
Last updated: August 12, 2013
Last verified: August 2013
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Enrollment: 300
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
R343 1mg, 1 puff bid R343 2mg, 2 puffs bid
Other Name: R343
Placebo Comparator: Placebo x 1, 1 puff bid
1 x Placebo, 1 puff bid
Drug: Placebo
Placebo x 1, 1 puff bid Placebo x 2, 2 puffs bid
Other Name: Placebo
Placebo Comparator: Placebo x 2, 2 puffs bid
2 x Placebo, 2 puffs bid
Drug: Placebo
Placebo x 1, 1 puff bid Placebo x 2, 2 puffs bid
Other Name: Placebo
Active Comparator: R940343 1mg, 1 puff bid
R343 1mg, 1 puff bid
Drug: R940343
R343 1mg, 1 puff bid R343 2mg, 2 puffs 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 into 1 of 4 dosing groups

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591044

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

No publications provided

Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01591044     History of Changes
Other Study ID Numbers: C-940343-004
Study First Received: April 30, 2012
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014