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

Rigel Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: R940343 2mg; Drug: Placebo; Drug: R940343 1mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591044

C-940343-004

Details and patient eligibility

About

The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical history of asthma
• Ability to perform spirometry

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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301 participants in 3 patient groups, including a placebo group

R940343 2mg, 2 puffs bid

Active Comparator group

Description:

R343 2mg, 2 puffs bid

Treatment:

Drug: R940343 2mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

R940343 1mg, 1 puff bid

Active Comparator group

Description:

R343 1mg, 1 puff bid

Treatment:

Drug: R940343 1mg