Status:
COMPLETED
Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects
Lead Sponsor:
Icagen
Conditions:
Atopic Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.
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
- History of asthma (as defined by the Global Initiative in Asthma definition or having been previously treated for asthma);
- Baseline (pre-bronchodilator) forced expiratory volume at one second (FEV1) ≥70% of predicted;
- Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests );
- Positive response on screening to skin prick test to either house dust mite, cat hair, or grass pollen;
- A positive inhaled methacholine challenge with a PC20 ≤ 8 mg/mL (within 6 months prior to Screening Visit 1);
- Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of equal to or more than 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. 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;
- Non-smoker (refrained from any tobacco usage or any products containing nicotine for 6 months prior to Screening Visit 1);
- Able and willing to give written informed consent to participate in the study.
Exclusion
- Any subject who has experienced any allergic reaction to a drug that suggests an increased potential for a hypersensitivity to senicapoc (e.g. clotrimazole);
- Previous ingestion of senicapoc (ICA-17043) prior to Screening Visit 1;
- Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs;
- Respiratory tract infection or asthma exacerbation within 4 weeks of the first Screening Visit or within the period between Screening Visit 1 and Day 1 unless study physician believes lung function was unaffected (no greater than 10% decrease in baseline FEV1) by such event;
- Considering or scheduled to undergo any surgical procedure during the duration of the study;
- History of alcohol and/or drug abuse within 2 years prior to Screening Visit 1;
- Donation of blood (\>450 mL) or significant loss of blood within 56 days prior to Screening Visit 1;
- Received any commercially licensed investigational product within 30 days prior to Screening Visit 1 or received any unlicensed investigational product within 90 days prior to Screening Visit 1;
- History of chronic hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infection, or demonstration of HIV antibodies;
- A positive qualitative urine drug test, a positive urine or breath alcohol test, or a positive urine cotinine or CO breath test at the first Screening visit or on Day 1;
- Use of oral or inhaled or intranasal corticosteroid, long acting beta agonists (e.g., salmeterol or formoterol), leukotriene receptor antagonists (e.g., zafirlukast or montelukast), theophylline, nedocromil sodium, cromolyn sodium, zileuton , or anti-cholinergic agents within the 28 days prior to the first Screening visit;
- Use of oral antihistamines within 1 week prior to the first Screening visit;
- Symptomatic with hay fever during any of the Screening Visits or Day 1;
- A \>10 pack year cigarette history.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00861211
Start Date
October 1 2008
End Date
May 1 2009
Last Update
July 14 2011
Active Locations (2)
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1
Guy's Drug Research Unit
London, UK, United Kingdom, SE1 1YR
2
Medicines Evaluation Unit
Manchester, UK, United Kingdom, M23 9QZ