The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Unnamed facility
Huntington Beach, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Normal, Illinois, United States
Unnamed facility
Metairie, Louisiana, United States
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
- 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
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Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Skillman, New Jersey, United States
Unnamed facility
North Syracuse, New York, United States
Unnamed facility
Canton, Ohio, United States
Unnamed facility
Seattle, Washington, United States