The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Drug: phenylephrine
* Drug: pseudoephedrine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skin test positive for the grass pollen allergen used in the chamber at Screening or within the prior 12 months. A negative urine pregnancy test at Screening and at monthly intervals for female subjects of childbearing potential. The following minimum scores at an evaluation time point during each of the 120-minute screening period challenge sessions: Nasal Congestion Score of at least 2 (moderate); Total Nasal Symptoms Score of at least 6; Total Non-nasal Symptoms Score of at least 2. Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations. Exclusion Criteria : An upper or lower respiratory tract infection within 4 weeks before Screening. Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator. A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenylephrine, Pseudoephedrine, Placebo<br>Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. | Drug: phenylephrine<br>* immediate-release 12 mg capsules for oral administration<br>Drug: pseudoephedrine<br>* 60 mg immediate-release tablets for oral administration<br>Drug: placebo<br>* placebo capsules<br>|
| Experimental: Pseudoephedrine, Placebo, Phenylephrine<br>Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. | Drug: phenylephrine<br>* immediate-release 12 mg capsules for oral administration<br>Drug: pseudoephedrine<br>* 60 mg immediate-release tablets for oral administration<br>Drug: placebo<br>* placebo capsules<br>|
| Experimental: Placebo, Phenylephrine, Pseudoephedrine<br>Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. | Drug: phenylephrine<br>* immediate-release 12 mg capsules for oral administration<br>Drug: pseudoephedrine<br>* 60 mg immediate-release tablets for oral administration<br>Drug: placebo<br>* placebo capsules<br>|
| Experimental: Phenylephrine, Placebo, Pseudoephedrine<br>Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. | Drug: phenylephrine<br>* immediate-release 12 mg capsules for oral administration<br>Drug: pseudoephedrine<br>* 60 mg immediate-release tablets for oral administration<br>Drug: placebo<br>* placebo capsules<br>|
| Experimental: Pseudoephedrine, Phenylephrine, Placebo<br>Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. | Drug: phenylephrine<br>* immediate-release 12 mg capsules for oral administration<br>Drug: pseudoephedrine<br>* 60 mg immediate-release tablets for oral administration<br>Drug: placebo<br>* placebo capsules<br>|
| Experimental: Placebo, Pseudoephedrine, Phenylephrine<br>Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. | Drug: phenylephrine<br>* immediate-release 12 mg capsules for oral administration<br>Drug: pseudoephedrine<br>* 60 mg immediate-release tablets for oral administration<br>Drug: placebo<br>* placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo | 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. | Baseline to endpoint (6 hour period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. | To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo The values for the nasal congestion score 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. | Baseline to endpoint (6 hour period) |