Allergic Rhinitis
Conditions
Keywords
allergic rhinitis, human, clinical trial, efficacy, safety, challenge test
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 studied in treatment groups of 18 to 21 subjects. The placebo group will also consist of 18 to 21 subjects. There will be a screening period of up to six weeks. There will be a follow up one to three weeks after the last dose of study drug.
Interventions
DRUGOC000459
Tablets twice daily for 8 days Dose level 1
DRUGPlacebo
Tablets twice daily for 8 days Dose level 5
Sponsors
Oxagen Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total nasal symptom score (TNSS) | After 8 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Other symptom scores of allergic rhinitis | After 8 days of treatment |
Countries
Austria
Outcome results
None listed