Allergic Rhinitis
Conditions
Keywords
Hay fever, biomarkers
Brief summary
This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge.
Interventions
DRUGFluticasone Propionate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* No signs or symptoms of rhinitis outside of the relevant airborne allergen season.
Exclusion criteria
* History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments. * Symptoms of rhinitis at inclusion indicated by total VAS score of \>40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score \>20. * Subjects not showing a nasal response to allergen concentration =\< 10,000 BU/ml. * Subjects with positive skin prick test for Dust House Mite.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in expression of key allergy targets in the nose following exposure to allergen. Assessment of protein expression measured by western blotting and immunohistochemistry in nasal biopsy tissue. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of corticosteroids treatment on the change in target expression following allergen challenge. Nasal lavage fluid and nasal secretions will be measured by ELISA and chemiluminescent assay. | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed