Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Mometasone Furoate Nasal Spray (Drug); fluticasone nasal spray (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Overall product preference based on subjects' answer to the question "which product do you prefer overall"
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: December 2004
Last updated: June 29, 2015
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