EUCTR2007-000017-11-AT进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Oxagen Ltd.
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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.
研究者
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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 daysMedDRA version: 19.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855Allergic rhinitisEUCTR2008-001659-24-ATOxagen Ltd.
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