A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: OC000459

• Registration Number: NCT01448902
• Lead Sponsor: Oxagen Ltd

Brief Summary

The study will 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. This is a randomised, double blind, placebo controlled, two way crossover evaluation. There will be a screening period of up to three weeks and a washout period of at least one week between the two treatment periods. There will be a follow up one to three weeks after the last dose of study drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2011-07-27
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-06
• Last Update Submitted: 2011-10-06
• Study First Posted: 2011-10-07
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
• 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.
• FEV1 within normal limits (≥90% of predicted).
• Atopy defined by a positive cutaneous response to mixed grass pollen within the last 12 months or at screening.
• Asymptomatic at screening
• Non smokers for at least the past 12 months

Exclusion Criteria

• Medical conditions likely to affect the outcome of the study.
• 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.
• Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function
• Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
OC000459	OC000459	-

Primary Outcome Measures

Name	Time	Method
Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score	8 days	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 as shown by the effect on Total Nasal Symptom Score

Secondary Outcome Measures

Name	Time	Method
OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs	8 days	To assess the safety of this treatment schedule in male subjects with allergic rhinitis as assessed via adverse events, clinical chemistry and haematology, FEV1 and vital signs.
OC000459 plasma concentration (Cmin)	8 days	To assess plasma levels of OC000459 at the time of allergen challenge (trough plasma level).

Trial Locations

Locations (1)

Vienna Challenge Chamber; 🇦🇹 Vienna, Austria