Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects

NCT00861211 | Completed Phase 2

• 1 other identifier: ICA-17043-17
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.

Conditions

Atopic Asthma

Keywords

asthma; inflammation; bronchoconstriction; allergen challenge; KCa3.1

Outcome Measures

Primary Outcomes (1)

• Decrease in FEV1 between 4-10 hours (Late Asthmatic Response) after allergen challenge and will compare the active (40 mg QD) vs. placebo treatment groups with respect to change in response to allergen challenge.

  after 2 weeks of treatment with study medication

Secondary Outcomes (1)

• Early allergen response to allergen challenge, measure of airway hyperreactivity to methacholine challenge, pulmonary function tests (FEV1 and FVC), fraction of exhaled NO, cell differentials and cytokine measurements from induced sputum samples.

  after 2 weeks of study medication

Study Arms (2)

Active treatment arm

EXPERIMENTAL

Drug: senicapoc

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

senicapoc DRUG

Loading Dose: 80 mg twice daily x 3 days followed by Maintenance Dose: 40 mg daily x 11 days

Also known as: ICA-17043

Active treatment arm

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icagen: lead

Study Sites (2)

Guy's Drug Research Unit

London, UK, SE1 1YR, United Kingdom

Location

Medicines Evaluation Unit

Manchester, UK, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

senicapoc

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tak H Lee, FRCP

  Guy's Drug Research Unit, Quintiles Limited

  PRINCIPAL INVESTIGATOR

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: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

GB (2)