Exercise Induced Asthma Clinical Trial
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
Verified date | July 2011 |
Source | Icagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
Status | Completed |
Enrollment | 69 |
Est. completion date | September 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Able and willing to give written informed consent to participate in the study as HIPAA authorization; - Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests - History of physician-diagnosed asthma according to Global Initiative for Asthma, AND exercise-induced asthma/ bronchoconstriction; - Current treatment for asthma with short-acting inhaled beta-2-agonist ONLY; - Baseline FEV1 >65% of predicted at Screen Visit 1; - A 20% or greater drop in FEV1 following exercise challenge on at least two separate occasions prior to enrollment; - Non-smoker (refrained from any tobacco usage, or any products containing nicotine, for 6 months prior to Day 1); Exclusion Criteria: - Subject who has experienced any allergic reaction to a drug which, suggests an increased potential for a hypersensitivity to senicapoc (e.g., clotrimazole); - Previous ingestion of senicapoc (ICA-17043) - Pregnant or lactating female; - Condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; subjects who have had any previous gastrointestinal surgery, except appendectomy or cholecystectomy (if performed more than 90 days prior to Screening Visit 1) or a history of clinically significant active cardiovascular, neurologic, endocrine, hepatic, or renal disorders; - 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). - Treatment for conditions other than asthma with systemic corticosteroids within 1 month prior to Visit 1. - Asthma exacerbation having necessitated treatment with inhaled corticosteroids within 6 weeks prior to study Screening Visit 1. - History of severe asthma as defined by use of oral/injectable corticosteroids within the last 3 months and/or more than two bursts in the last year. - Undergoing desensitization therapy unless on a maintenance dose for at least 3 months prior to entry and will continue as such throughout study participation. - History of chronic pulmonary diseases other than asthma. - Considering or scheduled to undergo any surgical procedure during the duration of the study; - Ingestion of any investigational medication within 30 days prior to Screening Visit 1; - A positive plasma alcohol, or urine cotinine test at Screening Visit 1; - Use of the following asthma medications for the stated period prior to Screening Visit 1 and throughout the study: - Oral or parenteral corticosteroids within 3 months prior to Screening Visit 1 - Inhaled corticosteroids (ICS) (e.g., budesonide, fluticasone propionate) within 1 month prior to Screening Visit 1 - long acting beta agonists; leukotriene receptor antagonists; or anti-cholinergic agents (e.g. tiotropium) within the 2 weeks prior to Screening Visit; - Use of antihistamines within 3 days prior to Screening Visit 1; - Has a >10 pack-year history of smoking; - Hypertension at screen (BP > 150/90), if deemed by Investigator to be unfit to complete exercise challenge testing; - Screen QTc > 450 msec or ECG not suitable for QT measurement (e.g., poorly defined termination of T-wave); - After exercise challenge test, subject not recovering to at least 90% of baseline FEV1 following administration of short-acting beta-2-agonist. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Icagen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change from baseline in the maximal percentage decrease in forced expiratory volume in one second (FEV1) after exercise | Week 2 and Week 4 | No | |
Secondary | - 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. | Week 2 and Week 4 | No |
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