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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783458
• Other study ID #: P04208
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2004
• Est. completion date: January 1, 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2005
• Est. primary completion date: January 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall product preference based on subjects' answer to the question "which product do you prefer overall"		On the study day, after dose of each product
Secondary	Subject ratings for individual product attributes		On the study day, after dose of each product
Secondary	Subject rating for likely compliance with daily dosing,		On the study day, after dose of each product
Secondary	Subject preference for glass or plastic bottle		On the study day, after dose of each product
Secondary	Subject response to if they would want a prescription for their preferred product and if they would recommend the product		On the study day, after dose of each product
Secondary	Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor,		On the study day, after dose of each product