A dose-finding 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, parallel group evaluation of the dose response curve and minimum effective dose given orally for eight days

Phase 1

• Conditions: Allergic rhinitis; MedDRA version: 19.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855

• Registration Number: EUCTR2008-001659-24-AT
• Lead Sponsor: Oxagen Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-15
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening. Acceptable contraception includes the use of TWO of the following: oral contraception (i.e. the Pill); intrauterine device (an IUD or ‘Coil’); barrier contraception (i.e. condoms or diaphragm/cap); transdermal patch
2. Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by case 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 total nasal symptom score of <4 at screening and on Day 1 of the treatment period.
6. Non smokers for at least the past 3 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 up to 1500 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 12-lead electrocardiogram (ECG) that is normal or without clinically-significant abnormalities determined at screening by the principal investigator or designee.
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

Exclusion Criteria

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 as determined by the principal investigator or designee.
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 in the past 28 days
5. Use of inhaled or local corticosteroids in the past 28 days.
6. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator or designee, would limit compliance with the protocol.
7. 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 the treatment period.
8. Clinically significant abnormality in clinical laboratory tests at screening as determined by the principal investigator or designee.
9. The subject has participated in a study with a new molecular entity (drug not currently marketed) during the previous four months or any other trial during the previous three months.
10. The subject regularly, or on average, drinks more than four units of alcohol per day. One unit of alcohol is defined as a medium (125ml) glass of wine, half a pint (250ml) of beer or one measure (24ml) of spirits)
11. A history of gastrointestinal disorder likely to influence drug absorption.
12. Receipt of forbidden 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.
13. Inability to communicate well with the investigator (i.e. language problem, poor mental development or impaired cerebral function).
14. Donation of 450ml or more blood within the previous 12 weeks.
15. A history of hypersensitivity and/or idiosyncrasy to any of the excipients employed in this study.
16. 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: The primary objective of the study is to explore the efficacy of a range of doses of OC000459 when subjects are challenged with allergen in the Vienna Challenge Chamber for 6 hours.;Secondary Objective: •To assess the safety of this treatment schedule in male and female subjects with allergic rhinitis.<br>•To assess plasma levels of OC000459 at the time of allergen challenge.<br>;Primary end point(s): Primary efficacy endpoint: <br>Total nasal symptom score on Day 8. <br>