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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Mometasone Furoate Nasal Spray; Drug: fluticasone nasal spray

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nasonex Followed by Flonase	Drug: Mometasone Furoate Nasal Spray; One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray; Other Names: Nasonex, SCH 032088; Drug: fluticasone nasal spray; One dose (2 sprays in each nostril) of fluticasone nasal spray; Other Names: Flonase®
Active Comparator: Flonase Followed by Nasonex	Drug: Mometasone Furoate Nasal Spray; One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray; Other Names: Nasonex, SCH 032088; Drug: fluticasone nasal spray; One dose (2 sprays in each nostril) of fluticasone nasal spray; Other Names: Flonase®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Subject ratings for individual product attributes	On the study day, after dose of each product
Subject rating for likely compliance with daily dosing,	On the study day, after dose of each product
Subject preference for glass or plastic bottle	On the study day, after dose of each product
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
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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2004
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: January 5, 2009
• First Submitted That Met QC Criteria: January 5, 2009
• First Posted (Estimated): January 6, 2009

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Mometasone Furoate
• Other Study ID Numbers: P04207

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis