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Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-Induced Asthma
This study is currently recruiting participants.
Verified by Icagen, March 2009
First Received: March 12, 2009   Last Updated: March 13, 2009   History of Changes
Sponsored by: Icagen
Information provided by: Icagen
ClinicalTrials.gov Identifier: NCT00861185
  Purpose

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

MedlinePlus related topics: Asthma Exercise and Physical Fitness
U.S. FDA Resources
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

Further study details as provided by Icagen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

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)
Placebo: Placebo Comparator Drug: Placebo
Placebo looks identical to active study medication and will be dosed according to the same dosing regimen

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861185

Contacts
Contact: Jon Stocker, Ph.D. +1 (919) 281-5517 jstocker@icagen.com

Locations
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
Sponsors and Collaborators
Icagen
Investigators
Study Director: Jonathon Stocker, Ph.D. Icagen
  More Information

No publications provided

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

Keywords provided by Icagen:
bronchospasm
exercise asthma
inflammation
KCa3.1

Study placed in the following topic categories:
Asthma, Exercise-Induced
Hypersensitivity
Lung Diseases, Obstructive
Bronchial Spasm
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:
Asthma, Exercise-Induced
Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009