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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)

Primary Purpose

Rhinitis, Allergic, Seasonal

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
phenylephrine
pseudoephedrine
placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Phenylephrine, Pseudoephedrine, Placebo

    Pseudoephedrine, Placebo, Phenylephrine

    Placebo, Phenylephrine, Pseudoephedrine

    Phenylephrine, Placebo, Pseudoephedrine

    Pseudoephedrine, Phenylephrine, Placebo

    Placebo, Pseudoephedrine, Phenylephrine

    Arm Description

    Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.

    Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.

    Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

    Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

    Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.

    Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.

    Outcomes

    Primary Outcome Measures

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

    Full Information

    First Posted
    January 11, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00276016
    Brief Title
    The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    February 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis, Allergic, Seasonal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phenylephrine, Pseudoephedrine, Placebo
    Arm Type
    Experimental
    Arm Description
    Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.
    Arm Title
    Pseudoephedrine, Placebo, Phenylephrine
    Arm Type
    Experimental
    Arm Description
    Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
    Arm Title
    Placebo, Phenylephrine, Pseudoephedrine
    Arm Type
    Experimental
    Arm Description
    Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
    Arm Title
    Phenylephrine, Placebo, Pseudoephedrine
    Arm Type
    Experimental
    Arm Description
    Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
    Arm Title
    Pseudoephedrine, Phenylephrine, Placebo
    Arm Type
    Experimental
    Arm Description
    Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.
    Arm Title
    Placebo, Pseudoephedrine, Phenylephrine
    Arm Type
    Experimental
    Arm Description
    Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
    Intervention Type
    Drug
    Intervention Name(s)
    phenylephrine
    Intervention Description
    immediate-release 12 mg capsules for oral administration
    Intervention Type
    Drug
    Intervention Name(s)
    pseudoephedrine
    Intervention Description
    60 mg immediate-release tablets for oral administration
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo capsules
    Primary Outcome Measure Information:
    Title
    The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
    Description
    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.
    Time Frame
    Baseline to endpoint (6 hour period)
    Secondary Outcome Measure Information:
    Title
    The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
    Description
    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.
    Time Frame
    Baseline to endpoint (6 hour period)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19230461
    Citation
    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.
    Results Reference
    derived

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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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