Skip to main content
OpenTrials
Completed

NCT Number: NCT00817050

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mometasone Furoate Nasal spray

Drug

One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray

Other names: Nasonex, SCH 032088

fluticasone nasal spray

Drug

One dose (2 sprays in each nostril) of fluticasone nasal spray

Other names: Flonase®

Primary outcomes

  1. 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 outcomes

  1. Subject rating for likely compliance with daily dosing,

    Time frame: On the study day, after dose of each product

  2. Subject preference for glass or plastic bottle

    Time frame: On the study day, after dose of each product

  3. 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

  4. 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

  5. Subject ratings for individual product attributes

    Time frame: On the study day, after dose of each product

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 6, 2009
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.