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Sponsored by: |
Icagen |
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Information provided by: | Icagen |
ClinicalTrials.gov Identifier: | NCT00861211 |
The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.
Condition | Intervention | Phase |
---|---|---|
Atopic 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 Two Weeks of Oral Senicapoc Administration on Allergen Challenge in Atopic Asthmatic Subjects |
Estimated Enrollment: | 32 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active treatment arm: Experimental |
Drug: senicapoc
Loading Dose: 80 mg twice daily x 3 days followed by Maintenance Dose: 40 mg daily x 11 days
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo comparator
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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 allergen challenge in patients with allergic asthma. It is analogous to the study performed in animals in which senicapoc demonstrated the ability to reduce airway resistance and hyper-responsiveness induced by airway challenge with antigen and carbachol, respectively. This study is also the first to test the ability of senicapoc to reduce airway inflammation, which is the key pathophysiologic process in asthma. 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 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A positive inhaled methacholine challenge with a PC20 ≤ 8 mg/mL (within 6 months prior to Screening Visit
1);
The late asthmatic response must include a fall in FEV1 of equal to or more than 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen;
Exclusion Criteria:
United Kingdom, UK | |
Guy's Drug Research Unit | |
London, UK, United Kingdom, SE1 1YR | |
Medicines Evaluation Unit | |
Manchester, UK, United Kingdom, M23 9QZ |
Principal Investigator: | Tak H Lee, FRCP | Guy's Drug Research Unit, Quintiles Limited |
Responsible Party: | Icagen, Inc. ( Seth V. Hetherington, M.D. Sr. VP Clinical and Regulatory Affairs ) |
Study ID Numbers: | ICA-17043-17 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861211 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
asthma inflammation bronchoconstriction allergen challenge KCa3.1 |
Asthma Inflammation |