COX-2 Inhibition in Allergic Asthma
The study is part of a research programme into mechanisms of asthmatic airway obstruction, focusing on the role of lipid mediators such as the prostaglandins.
To this end the effect of a non-steroidal anti-inflammatory drug, the selective COX-2 inhibitor etoricoxib, will be evaluated in the allergen challenge setting in twelve subjects with intermittent allergic asthma. Active treatment for 10 to 13 days will be compared with an identical study period with no treatment in a cross-over, randomised design. Rising dose allergen challenges will be performed on three occasions to assess possible changes in airways responsiveness. Sampling of blood, urine, saliva and sputum will be done to allow for analyses of the production of prostaglandins and other lipid mediators, of the efficacy of COX-2 inhibition as well as of regulation of immune cells.
It is hypothesized that inhibition of COX-2 by virtue of inhibition of bronchoprotective prostaglandin E2 leads to a slightly exaggerated airway response to allergen exposure.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Effect of COX-2 Inhibition on Allergen-induced Airway Obstruction in Subjects With Asthma|
- Allergen PD20 FEV1 [ Time Frame: 10 to 13 days ] [ Designated as safety issue: Yes ]
- Urinary prostaglandin E2 and D2 concentrations [ Time Frame: 10-13 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
10-13 days treatment with etoricoxib
90 mg/day orally for 10-13 days
Other Name: Arcoxia