Back to resultsSingle 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
About this trial
This is an interventional treatment trial for Allergic Rhinitis
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.
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
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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