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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

Page last updated: August 23, 2015

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