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

Organon

Status and phase

Completed

Phase 4

Conditions

Allergic Rhinitis

Treatments

Drug: fluticasone nasal spray

Drug: Mometasone Furoate Nasal Spray

Study type

Interventional

Funder types

Industry

Identifiers

NCT00817050

P04207

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.