NCT01591044

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Placebo	1 puff bid or 2 puffs bid
DRUG	R940343 1mg	R343 1mg, 1 puff bid
DRUG	R940343 2mg	R343 2mg, 2 puffs bid

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-05-03
• Last updated: 2016-09-29
• Results posted: 2016-09-29

Locations

59 sites across 2 countries: United States, Canada