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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 : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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


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




Primary Outcome Measures :
  1. 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 :
  1. 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.




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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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00276016     History of Changes
Other Study ID Numbers: P04579
First Posted: January 12, 2006    Key Record Dates
Results First Posted: July 29, 2010
Last Update Posted: September 28, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Phenylephrine
Oxymetazoline
Ephedrine
Pseudoephedrine
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
Molecular Mechanisms of Pharmacological Action