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

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Seasonal
• Interventions: Drug: phenylephrine; Drug: pseudoephedrine; Drug: placebo

• Registration Number: NCT00276016
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Results First Submitted: 2010-04-01
• Results First Submitted QC: 2010-07-02
• Results First Posted: 2010-07-29
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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:

  1. Nasal Congestion Score of at least 2 (moderate);
  2. Total Nasal Symptoms Score of at least 6;
  3. 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pseudoephedrine, Phenylephrine, Placebo	placebo	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.
Phenylephrine, Pseudoephedrine, Placebo	phenylephrine	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.
Placebo, Phenylephrine, Pseudoephedrine	placebo	Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Placebo, Pseudoephedrine, Phenylephrine	placebo	Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Phenylephrine, Pseudoephedrine, Placebo	placebo	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.
Pseudoephedrine, Placebo, Phenylephrine	placebo	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Phenylephrine, Placebo, Pseudoephedrine	placebo	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Phenylephrine, Pseudoephedrine, Placebo	pseudoephedrine	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.
Pseudoephedrine, Placebo, Phenylephrine	phenylephrine	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Placebo, Phenylephrine, Pseudoephedrine	phenylephrine	Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Pseudoephedrine, Placebo, Phenylephrine	pseudoephedrine	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Phenylephrine, Placebo, Pseudoephedrine	phenylephrine	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Phenylephrine, Placebo, Pseudoephedrine	pseudoephedrine	Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Placebo, Phenylephrine, Pseudoephedrine	pseudoephedrine	Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Pseudoephedrine, Phenylephrine, Placebo	pseudoephedrine	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.
Pseudoephedrine, Phenylephrine, Placebo	phenylephrine	Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.
Placebo, Pseudoephedrine, Phenylephrine	phenylephrine	Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Placebo, Pseudoephedrine, Phenylephrine	pseudoephedrine	Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.	Baseline to endpoint (6 hour period)	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.