Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04208)(COMPLETED)

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Mometasone Furoate Nasal Spray
  • One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray
• Drug: fluticasone nasal spray
  • One dose (2 sprays in each nostril) of fluticasone nasal spray

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Nasonex Followed by Flonase
• Active Comparator: Flonase Followed by Nasonex

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Subject ratings for individual product attributes
  • Time Frame: On the study day, after dose of each product
    Safety Issue?: No
• Subject rating for likely compliance with daily dosing,
  • Time Frame: On the study day, after dose of each product
    Safety Issue?: No
• Subject preference for glass or plastic bottle
  • Time Frame: On the study day, after dose of each product
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00783458

Study ID Number: P04208

ClinicalTrials.gov Identifier: NCT00783458

Health Authority: United States: Food and Drug Administration