A study of the effects of OC000459 on responses to allergen challenge in the Vienna Chamber in subjects known to suffer from grass pollen induced allergic rhinitis: A randomised, double blind placebo controlled, two way crossover evaluation of a dose schedule of 200 mg given twice daily orally for eight days in male subjects
- Conditions
- history of symptoms of grass pollen related allergic rhinitis within the previous two yearsMedDRA version: 9.1Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollen
- Registration Number
- EUCTR2007-000017-11-AT
- Lead Sponsor
- Oxagen Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
2. Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
3. FEV1 within normal limits (=90% of predicted).
4. Atopy defined by a positive cutaneous response (wheal = 3mm compared to negative control) to mixed grass pollen within the last 12 months or at screening.
5. Asymptomatic at screening as characterized by:
a. Normal appearing nasal mucosa with no active allergic rhinitis.
b. A total nasal symptom score sheet on study entry so that subjects produce a score of <2 at screening and on Day 1 of treatment periods 1 and 2.
6. Non smokers for at least the past 12 months with a pack history = 1 pack years (Pack years = (No of cigarettes smoked/day/20) x No of years smoked).
7. A total nasal symptom score of at least 6 after challenge with =1400 grass pollen grains/m³ after 2 hours in the Vienna Challenge Chamber at the screening visit
8. A positive Radio Allergen Sorbent Test (= class 2) for grass pollen at the screening visit or in the previous 12 months.
9. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
10. Available to complete the study.
11. Subjects with a negative urinary drugs of abuse screen, determined at screening
12. Negative carbon monoxide test (smokerlyzer) or urinary cotinine test determined at screening
13. Negative alcohol breath test determined at screening
14. Subjects with a normal 12-lead electrocardiogram (ECG), determined at screening.
15. Negative test for HIV and Hepatitis B and C determined at screening.
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. Medical conditions likely to affect the outcome of the study.
2. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
3. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 = 90% predicted for height and age).
4. Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
5. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.
6. Infection of the upper airways/lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and at the start of each treatment period.
7. Clinically significant abnormality in clinical laboratory tests at screening as determined by the principal investigator.
8. The subject has participated in a study with a new molecular entity during the previous four months or any other trial during the previous three months.
9. The subject regularly, or on average, drinks more than four units of alcohol per day.
10. A history of gastrointestinal disorder likely to influence drug absorption.
11. Receipt of prescribed or over the counter medication within 14 days of the first study day and for the duration of the trial, including vitamins and herbal remedies.
12. Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function).
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. Subjects known to have tuberculosis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ·To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours.;Secondary Objective: ·To assess the safety of this treatment schedule in male subjects with allergic rhinitis.<br>·To assess plasma levels of OC000459 at the time of allergen challenge.<br>;Primary end point(s): Efficacy will be assessed as follows:<br><br>Primary efficacy endpoint: <br>Total nasal symptom score on Day 8 <br><br>Secondary efficacy endpoints:<br>Total nasal symptom score on Day 2 <br>Individual components of total nasal symptom score, Eye symptom score, Other symptom score, secretion weight, rhinomanometry and nasal endoscopy parameters on Day 2 and Day 8 <br><br>Safety will be assessed as follows:<br>Adverse events, clinical pathology (haematology and clinical chemistry) parameters, FEV1 and vital signs.<br>
- Secondary Outcome Measures
Name Time Method