Study to Compare the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Placebo on Symptoms in Patients With Allergic Rhinitis Within/Out of Season
A previous study has shown very clearly that the treatment with the combination of cetirizine and pseudoephedrine is superior to the treatment with the single agents regarding the reduction of symptoms in patients with allergic rhinitis. These data, obtained after controlled pollen exposure out of the pollen season, showed highly reproducible individual responses prior to dosing. It is not clear, however, whether the same results can be obtained during the pollen season, when additional natural pollen exposure may influence the variability of the individual reactions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy's Reproducibility of a Combination of Pseudoephedrine and Cetirizine on Symptom Scores and Rhinomanometry in Patients With Allergic Rhinitis Following Pollen Exposure in the Fraunhofer Environmental Challenge Chamber (ECC) in- and Outside the Grass Pollen Season|
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||February 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
The aim of this study is to evaluate prospectively, if reproducible results can be shown when testing a combination of cetirizine and pseudoephedrine in an Environmental Exposure Unit setting once inside and once outside the grass pollen season. An equivalent outcome would validate the ECC for testing anti-allergic substances during the pollen season in the future. Up to now these studies have been restricted to the pollen-free season.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474890
|Fraunhofer Institute for Toxicology and Experimental Medicine|
|Hannover, Germany, 30625|
|Principal Investigator:||Norbert Krug, Professor||Fraunhofer-Institute of Toxicology and Experimental Medicine|