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Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mometasone Furoate Nasal Spray
fluticasone nasal spray
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must have been 18-65 years of age, of either sex and any race.
  • Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of <6 but >2; congestion must have been <2.
  • Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations.
  • Subject must have understood and been able to adhere to the dosing and visit schedule.

Exclusion Criteria:

  • Subject had used any investigational product within 30 days prior to enrollment.
  • Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study.
  • Subject was participating in any other clinical study(ies).
  • Subject was using any nasal lavage fluid or spray.
  • Subject was using any perfume during the study day.
  • Subject was using any oral rinse during the study day.
  • Subject had used topical or oral nasal decongestants in the past 1 week.
  • Subject had used a nasal corticosteroid in the previous 2 weeks.
  • Subject had anosmia or ageusia (absence of the sense of smell or taste).
  • Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing.
  • Subject had a respiratory infection in the 2 weeks prior to testing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Nasonex Followed by Flonase

    Flonase Followed by Nasonex

    Arm Description

    Outcomes

    Primary Outcome Measures

    Overall product preference based on subjects' answer to the question "which product do you prefer overall"

    Secondary Outcome Measures

    Subject rating for likely compliance with daily dosing,
    Subject preference for glass or plastic bottle
    Subject response to if they would want a prescription for their preferred product and if they would recommend the product
    Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor,
    Subject ratings for individual product attributes

    Full Information

    First Posted
    January 5, 2009
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00817050
    Brief Title
    Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)
    Official Title
    A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2004 (Actual)
    Primary Completion Date
    January 1, 2005 (Actual)
    Study Completion Date
    January 1, 2005 (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 was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nasonex Followed by Flonase
    Arm Type
    Active Comparator
    Arm Title
    Flonase Followed by Nasonex
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone Furoate Nasal Spray
    Other Intervention Name(s)
    Nasonex, SCH 032088
    Intervention Description
    One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray
    Intervention Type
    Drug
    Intervention Name(s)
    fluticasone nasal spray
    Other Intervention Name(s)
    Flonase®
    Intervention Description
    One dose (2 sprays in each nostril) of fluticasone nasal spray
    Primary Outcome Measure Information:
    Title
    Overall product preference based on subjects' answer to the question "which product do you prefer overall"
    Time Frame
    On the study day, after dose of each product
    Secondary Outcome Measure Information:
    Title
    Subject rating for likely compliance with daily dosing,
    Time Frame
    On the study day, after dose of each product
    Title
    Subject preference for glass or plastic bottle
    Time Frame
    On the study day, after dose of each product
    Title
    Subject response to if they would want a prescription for their preferred product and if they would recommend the product
    Time Frame
    On the study day, after dose of each product
    Title
    Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor,
    Time Frame
    On the study day, after dose of each product
    Title
    Subject ratings for individual product attributes
    Time Frame
    On the study day, after dose of each product

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must have been 18-65 years of age, of either sex and any race. Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of <6 but >2; congestion must have been <2. Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations. Subject must have understood and been able to adhere to the dosing and visit schedule. Exclusion Criteria: Subject had used any investigational product within 30 days prior to enrollment. Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study. Subject was participating in any other clinical study(ies). Subject was using any nasal lavage fluid or spray. Subject was using any perfume during the study day. Subject was using any oral rinse during the study day. Subject had used topical or oral nasal decongestants in the past 1 week. Subject had used a nasal corticosteroid in the previous 2 weeks. Subject had anosmia or ageusia (absence of the sense of smell or taste). Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing. Subject had a respiratory infection in the 2 weeks prior to testing.

    12. IPD Sharing Statement

    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)

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