A PHASE II STUDY OF THE EFFICACY (AS ASSESSED BY BRONCHIAL ALLERGEN CHALLENGE) AND SAFETY OF OC000459 DOSED ORALLY (200mg BID WITH FOOD) IN SUBJECTS WITH ALLERGIC ASTHMA; IN A RANDOMISED, DOUBLE BLIND, TWO WAY BALANCED CROSSOVER COMPARING OC000459 WITH PLACEBO
- Conditions
- AsthmaMedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
- Registration Number
- EUCTR2005-005838-12-GB
- Lead Sponsor
- Oxagen Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
1. Male subjects, or female subjects (not of childbearing potential; women who have had hysterectomies or are post menopausal by more than two years), any racial group.
2. Aged 18-45 years inclusive.
3. Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists).
4. FEV1 >65% of predicted on at least two occasions at screening.
5. At the screening allergen challenge, a decrease in FEV1 of =20% in the early asthmatic reaction and of =15% in the LAR to allergen on 3 separate occasions between 4-10hrs post allergen, 2 of which must be consecutive.
6. No steroid usage in the past 12 weeks.
7. Able to comply with the protocol.
8. Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values at screening.
9. Subjects with a negative urinary drugs of abuse and cotinine screen or carbon monoxide breath test, determined at screening.
10. Subjects with negative HIV and Hepatitis B and C results determined at screening.
11. Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months.
12. Subjects must have provided written informed consent to participate in the study.
13. Non smokers for a minimum of 6 months; less than 10 pack year history.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. A history of gastrointestinal disorder likely to influence drug absorption.
2. Respiratory tract pathology other than allergic asthma.
3. Lower respiratory tract infection within 4 weeks prior to an allergen challenge.
4. Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period.
5. Receipt of short acting inhaled beta agonists within 8 hours of screening or of each study visit
6. Intake of alcohol within 48 hours of screening or of the first day of each dosing period
7. Intake of caffeine within 48 hours of screening or of each study visit
8. Performing strenuous exercise within 48 hours of screening or of the first day of each dosing period
9. Evidence of renal, hepatic, cardiovascular or metabolic dysfunction or any disorder requiring regular medication.
10. A history of drug or alcohol abuse.
11. Inability to give written informed consent and to comply with study procedures.
12. Participation in a clinical trial of an unlicensed drug within the previous 12 weeks.
13. Donation of 450 ml or more blood within the previous 12 weeks.
14. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
15. Any previous clinical trial involving the administration of OC000459.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method