Status:
COMPLETED
Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-induced Asthma
Lead Sponsor:
Icagen
Conditions:
Exercise Induced Asthma
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00861185
Start Date
March 1 2009
End Date
September 1 2009
Last Update
July 14 2011
Active Locations (9)
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1
Huntington Beach, California, United States, 92647
2
Orange, California, United States, 92868
3
Normal, Illinois, United States, 61761
4
Metairie, Louisiana, United States, 70006