Asthma MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: OC000459
Product Code: OC000459
Pharmaceutical Form: Capsule, hard
Current Sponsor code: OC000459
Concentration unit: mg m
Sponsors
Oxagen Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of OC000459 in comparison with placebo on fall in FEV1 during the late asthmatic response (LAR; 4-10 hours after allergen challenge) to inhaled allergen in subjects with allergic asthma.; Secondary Objective: · To assess the safety (including lung function) of OC000459 in comparison with placebo in subjects with allergic asthma. · To assess the effect of OC000459 in comparison to placebo on the early asthmatic response (EAR; FEV1 0-2 hours after allergen challenge) to inhaled allergen · To assess the effect of OC000459 on sputum eosinophilia following inhaled allergen. · To assess the effect of OC000459 on exhaled NO pre- and post-allergen. · To assess the effect of OC000459 on hyper-responsiveness to methacholine post –allergen challenge. · To assess the effect of OC000459 on eosinophil shape change in blood and to relate these changes to plasma drug concentrations ; Primary end point(s): The primary endpoint will be the diminution in the late asthmatic response to bronchial allergen challenge as measured by the AUC and the maximum of percentage reductions in FEV1 between 4 and 10 hours after allergen challenge. Secondary biological activity endpoints include the diminution of the early asthmatic response to bronchial allergen challenge measured by the AUC and the maximum of percentage reductions in FEV1 between 0 and 2 hours after allergen challenge, sputum eosinophilia after allergen challenge as measured by percentage of eosinophils and the number of cells per millilitre of sputum, the methacholine PC20 after allergen challenge and exhaled NO pre- and post-allergen. Safety endpoints will consist of adverse events, vital signs and clinical laboratory safety tests. | — |
Countries
United Kingdom
Outcome results
None listed