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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00276016

Purpose

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	Intervention	Phase
Rhinitis, Allergic, Seasonal	Drug: phenylephrine Drug: pseudoephedrine Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Ephedrine Hydrochloride Phenylephrine Phenylephrine hydrochloride Ephedrine Pseudoephedrine hydrochloride Oxymetazoline Oxymetazoline hydrochloride Pseudoephedrine Sulfate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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.

Enrollment:	39
Study Start Date:	January 2006
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

No publications provided by Schering-Plough

Additional 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.

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00276016 History of Changes
Other Study ID Numbers:	P04579
Study First Received:	January 11, 2006
Results First Received:	April 1, 2010
Last Updated:	October 22, 2010
Health Authority:	Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Pseudoephedrine
Phenylephrine
Oxymetazoline
Ephedrine
Nasal Decongestants

Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012