Clinical Trial: Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-induced Asthma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of Four Weeks of Oral Senicapoc Administration on Exe

Brief Summary: The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.

Detailed Summary: Based on the unmet medical need for new agents in the treatment of asthma and the role of KCa3.1 in the function of several different cell types involved in the inflammatory response, and the effects seen in an animal model of allergic asthma, it is reasonable to explore the utility of senicapoc, a KCa3.1 blocker, as a novel treatment of asthma. This study will test the ability of senicapoc to alleviate bronchospasm induced by an exercise challenge in subjects with asthma. Exercise challenge studies have been conducted for many currently approved asthma medications. Exercise challenge studies provide a controlled environment and test conditions to investigate the potential usefulness of novel study drugs for the treatment of asthma. This study will be the first to test the ability of senicapoc to reduce airway bronchospasm after exercise challenge, which is one clinically important manifestation of asthma seen in patients. In summary, with a demonstrated safety profile across a wide range of doses in humans and efficacy in an animal model of allergic bronchospasm and hyper-responsiveness, the initiation of exploratory studies of senicapoc for treatment of asthma is justified.
Sponsor: Icagen

Current Primary Outcome: The change from baseline in the maximal percentage decrease in forced expiratory volume in one second (FEV1) after exercise [ Time Frame: Week 2 and Week 4 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: - Area under the curve (AUC) for FEV1 after exercise challenge, - the length of time for recovery of FEV1 after exercise challenge, - changes in non-challenge pulmonary function tests, and an asthma control questionnaire. [ Time Frame: Week 2 and Week 4 ]

Original Secondary Outcome: Same as current

Information By: Icagen

Dates:
Date Received: March 12, 2009
Date Started: March 2009
Date Completion:
Last Updated: July 8, 2011
Last Verified: July 2011