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Completed

NCT Number: NCT01591044

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Joseph Greenbaum, MD, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical history of asthma
  • Ability to perform spirometry

Exclusion criteria

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

Treatment and study plan

Placebo

Drug

1 puff bid or 2 puffs bid

R940343 1mg

Drug

R343 1mg, 1 puff bid

Other names: R343

R940343 2mg

Drug

R343 2mg, 2 puffs bid

Other names: R343

Primary outcomes

  1. Change in FEV1

    Time frame: Baseline and Week 8

    Change from baseline in pre-BD FEV1 (% predicted) at Week 8.

Sponsors and collaborators

Lead sponsor

Rigel Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: SITAR

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 3, 2012
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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