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

NCT00817050 | Completed Phase 4

• 1 other identifier: P04207
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Subject ratings for individual product attributes

  On the study day, after dose of each product

Study Arms (2)

Nasonex Followed by Flonase

ACTIVE COMPARATOR

Drug: Mometasone Furoate Nasal Spray; Drug: fluticasone nasal spray

Flonase Followed by Nasonex

ACTIVE COMPARATOR

Drug: Mometasone Furoate Nasal Spray; Drug: fluticasone nasal spray

Interventions

Mometasone Furoate Nasal Spray DRUG

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

Also known as: Nasonex, SCH 032088

Flonase Followed by Nasonex; Nasonex Followed by Flonase

fluticasone nasal spray DRUG

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

Also known as: Flonase®

Flonase Followed by Nasonex; Nasonex Followed by Flonase

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstadienes; Androstenes; Androstanes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: December 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: August 15, 2024

Record last verified: 2022-02