Clinical trial NCT01448902: A Study Of The Effects Of OC000459 In Subjects Known To Suffer From Grass Pollen Induced Allergic Rhinitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
CRTH2
Lead sponsor: Oxagen Ltd
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of OC00045 on response to allergen challenge as measured by change in Total Nasal Symptom Score
timeFrame: 8 days
Secondary outcomes:
measure: OC000459 safety as determined by adverse events, laboratory parameters, lung function and vital signs
timeFrame: 8 days
measure: OC000459 plasma concentration (Cmin)
timeFrame: 8 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Challenge Chamber
Study officials:
affiliation: Vienna Challenge Chamber
name: Friedrich Horak, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Collins LP, Hunter MG, Steiner J, Lewis T, Payton MA, Perkins CM, Pettipher R. The CRTH2 antagonist OC000459 reduces nasal and ocular symptoms in allergic subjects exposed to grass pollen, a randomised, placebo-controlled, double-blind trial. Allergy. 2012 Dec;67(12):1572-9. doi: 10.1111/all.12042. Epub 2012 Oct 1.