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Completed

NCT Number: NCT00276016

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

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.

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Key information

Conditions

Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phenylephrine

Drug

immediate-release 12 mg capsules for oral administration

pseudoephedrine

Drug

60 mg immediate-release tablets for oral administration

Placebo

Drug

placebo capsules

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 12, 2006
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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