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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: R940343 1mg; Drug: R940343 2mg; Drug: Placebo

• Registration Number: NCT01591044
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2016-05-17
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-05
• Results First Posted: 2016-09-29
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Clinical history of asthma
• Ability to perform spirometry

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R940343 1mg, 1 puff bid	R940343 1mg	R343 1mg, 1 puff bid
R940343 2mg, 2 puffs bid	R940343 2mg	R343 2mg, 2 puffs bid
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in FEV1	Baseline and Week 8	Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

Trial Locations

Locations (59)

California Research Medical Group, Inc; 🇺🇸 Fullerton, California, United States

Allergy Medical Clinic Research Division; 🇺🇸 Los Angeles, California, United States

California Allergy & Asthma Medical Group, INC; 🇺🇸 Los Angeles, California, United States

Southern California Institute for Respiratory Diseases, Inc.; 🇺🇸 Los Angeles, California, United States

Allergy & Asthma Associates of Southern California; 🇺🇸 Mission Viejo, California, United States

CHOC PSF, AMC, Division of Allergy, Asthma & Immunology; 🇺🇸 Orange, California, United States

Peninsula Research Associates; 🇺🇸 Rolling Hills Estates, California, United States

Allergy Associates Medical Group. Inc.; 🇺🇸 San Diego, California, United States

Allergy & Asthma Med Group/Research Center; 🇺🇸 San Diego, California, United States

Allergy & Asthma Associates of Santa Clara Valley; 🇺🇸 San Jose, California, United States

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