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

NCT ID: NCT00783458

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-01
• Study Completion Date: 2005-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nasonex Followed by Flonase

Group Type: ACTIVE_COMPARATOR

Mometasone Furoate Nasal Spray

Intervention Type: DRUG

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

fluticasone nasal spray

Intervention Type: DRUG

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

Flonase Followed by Nasonex

Group Type: ACTIVE_COMPARATOR

Mometasone Furoate Nasal Spray

Intervention Type: DRUG

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

fluticasone nasal spray

Intervention Type: DRUG

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

Interventions

Mometasone Furoate Nasal Spray

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

Intervention Type: DRUG

fluticasone nasal spray

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

Intervention Type: DRUG

Other Intervention Names

Nasonex, SCH 032088; Flonase®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04208

Identifier Type: -

Identifier Source: org_study_id