Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-induced Asthma

NCT00861185 | Completed Phase 2

• 1 other identifier: ICA-17043-18
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.

Conditions

Exercise Induced Asthma

Keywords

bronchospasm; exercise asthma; inflammation; KCa3.1

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the maximal percentage decrease in forced expiratory volume in one second (FEV1) after exercise

  Week 2 and Week 4

Secondary Outcomes (1)

• - 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

Study Arms (2)

Senicapoc

EXPERIMENTAL

Drug: senicapoc

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

senicapoc DRUG

Loading Dose: 80 mg twice daily x 3 days Maintenance Dose: 40 mg daily for remainder of the treatment period (total 4 weeks)

Also known as: ICA-17043

Senicapoc

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Icagen: lead

Study Sites (9)

Unknown Facility

Huntington Beach, California, 92647, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Normal, Illinois, 61761, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

St Louis, Missouri, 63141, United States

Location

Unknown Facility

Skillman, New Jersey, 08558, United States

Location

Unknown Facility

North Syracuse, New York, 13212, United States

Location

Unknown Facility

Canton, Ohio, 44718, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Asthma, Exercise-Induced; Bronchial Spasm; Inflammation

Interventions

senicapoc

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathon Stocker, Ph.D.

  Icagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

US (9)