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

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ClinicalTrials.gov Identifier: NCT00276016

Recruitment Status : Completed

First Posted : January 12, 2006

Results First Posted : July 29, 2010

Last Update Posted : February 9, 2022

Sponsor:

Information provided by (Responsible Party):

Organon and Co

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic, Seasonal	Drug: phenylephrine Drug: pseudoephedrine Drug: placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	January 2006
Actual Primary Completion Date :	February 2006
Actual Study Completion Date :	February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Pseudoephedrine Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phenylephrine, Pseudoephedrine, Placebo Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.	Drug: phenylephrine immediate-release 12 mg capsules for oral administration Drug: pseudoephedrine 60 mg immediate-release tablets for oral administration Drug: placebo placebo capsules
Experimental: Pseudoephedrine, Placebo, Phenylephrine Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.	Drug: phenylephrine immediate-release 12 mg capsules for oral administration Drug: pseudoephedrine 60 mg immediate-release tablets for oral administration Drug: placebo placebo capsules
Experimental: Placebo, Phenylephrine, Pseudoephedrine Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Drug: phenylephrine immediate-release 12 mg capsules for oral administration Drug: pseudoephedrine 60 mg immediate-release tablets for oral administration Drug: placebo placebo capsules
Experimental: Phenylephrine, Placebo, Pseudoephedrine Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.	Drug: phenylephrine immediate-release 12 mg capsules for oral administration Drug: pseudoephedrine 60 mg immediate-release tablets for oral administration Drug: placebo placebo capsules
Experimental: Pseudoephedrine, Phenylephrine, Placebo Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.	Drug: phenylephrine immediate-release 12 mg capsules for oral administration Drug: pseudoephedrine 60 mg immediate-release tablets for oral administration Drug: placebo placebo capsules
Experimental: Placebo, Pseudoephedrine, Phenylephrine Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.	Drug: phenylephrine immediate-release 12 mg capsules for oral administration Drug: pseudoephedrine 60 mg immediate-release tablets for oral administration Drug: placebo placebo capsules

Outcome Measures

Primary Outcome Measures :

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo [ Time Frame: 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 :

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo. [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Yao R, Staudinger H, Danzig M. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna Challenge Chamber. Ann Allergy Asthma Immunol. 2009 Feb;102(2):116-20. doi: 10.1016/S1081-1206(10)60240-2.

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Responsible Party:	Organon and Co
ClinicalTrials.gov Identifier:	NCT00276016
Other Study ID Numbers:	P04579
First Posted:	January 12, 2006 Key Record Dates
Results First Posted:	July 29, 2010
Last Update Posted:	February 9, 2022
Last Verified:	February 2022

Additional relevant MeSH terms:

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Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Phenylephrine Oxymetazoline Pseudoephedrine	Ephedrine Cardiotonic Agents Mydriatics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents

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