Last reviewed · How we verify
Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 39 |
| Start date | 2006-01 |
| Completion | 2006-02 |
Conditions
- Rhinitis, Allergic, Seasonal
Interventions
- phenylephrine
- pseudoephedrine
- placebo
Primary outcomes
- The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo — Baseline to endpoint (6 hour period)
To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.