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

Study Overview
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Brief Summary
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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.

Official Title
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A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Mometasone Furoate Nasal Spray
* Drug: fluticasone nasal spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |