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Sponsored by: |
Icagen |
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Information provided by: | Icagen |
ClinicalTrials.gov Identifier: | NCT00861185 |
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
Condition | Intervention | Phase |
---|---|---|
Exercise Induced Asthma |
Drug: senicapoc Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 Exercise-Induced Asthma |
Estimated Enrollment: | 64 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Senicapoc: Experimental |
Drug: senicapoc
Loading Dose: 80 mg twice daily x 3 days Maintenance Dose: 40 mg daily for remainder of the treatment period (total 4 weeks)
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo looks identical to active study medication and will be dosed according to the same dosing regimen
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Infectious illness, e.g. acute bacterial, acute and chronic parasitic, fungal infection or viral infection within 6 weeks prior to Screening Visit
1 or between Screening Visit 1 and Day 1 (Randomization).
Use of the following asthma medications for the stated period prior to Screening Visit 1 and throughout the study:
within the 2 weeks prior to Screening Visit;
Contact: Jon Stocker, Ph.D. | +1 (919) 281-5517 | jstocker@icagen.com |
United States, California | |
Recruiting | |
Orange, California, United States, 92868 | |
Recruiting | |
Huntington Beach, California, United States, 92647 | |
United States, Illinois | |
Recruiting | |
Normal, Illinois, United States, 61761 | |
United States, Louisiana | |
Recruiting | |
Metairie, Louisiana, United States, 70006 | |
United States, Missouri | |
Recruiting | |
St. Louis, Missouri, United States, 63141 | |
United States, New Jersey | |
Recruiting | |
Skillman, New Jersey, United States, 08558 | |
United States, New York | |
Recruiting | |
North Syracuse, New York, United States, 13212 | |
United States, Ohio | |
Recruiting | |
Canton, Ohio, United States, 44718 | |
United States, Washington | |
Recruiting | |
Seattle,, Washington, United States, 98105 |
Study Director: | Jonathon Stocker, Ph.D. | Icagen |
Responsible Party: | Icagen, Inc. ( Seth V. Hetherington, M.D. Sr. VP Clinical and Regulatory Affairs ) |
Study ID Numbers: | ICA-17043-18 |
Study First Received: | March 12, 2009 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00861185 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bronchospasm exercise asthma inflammation KCa3.1 |
Asthma, Exercise-Induced Hypersensitivity Lung Diseases, Obstructive Bronchial Spasm Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity Inflammation |
Asthma, Exercise-Induced Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases |
Bronchial Diseases Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |