Status:
COMPLETED
OC000459 Dose Finding Study in Hay Fever Sufferers.
Lead Sponsor:
Oxagen Ltd
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis
Detailed Description
This will be a randomised, double blind, placebo controlled, parallel group evaluation of OC000459 given orally for eight days. Four dose levels will be studied and compared to placebo. They will be s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 as determined by the principal investigator or designee.
- 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).
- Immunotherapy treatment course in the past 28 days
- Use of inhaled or local corticosteroids in the past 28 days.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00697281
Start Date
May 1 2008
End Date
September 1 2008
Last Update
February 24 2009
Active Locations (1)
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1
Allergie Zentrum Wien West, Vienna Challenge Chamber
Vienna, Austria, 1150 VIENNA