NCT00817050CompletedPhase 4
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 100
- Primary Endpoint
- Overall product preference based on subjects' answer to the question "which product do you prefer overall"
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 <
- •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.
Arms & Interventions
Nasonex Followed by Flonase
Active Comparator
Intervention: Mometasone Furoate Nasal Spray (Drug)
Nasonex Followed by Flonase
Active Comparator
Intervention: fluticasone nasal spray (Drug)
Flonase Followed by Nasonex
Active Comparator
Intervention: Mometasone Furoate Nasal Spray (Drug)
Flonase Followed by Nasonex
Active Comparator
Intervention: fluticasone nasal spray (Drug)
Outcomes
Primary Outcomes
Overall product preference based on subjects' answer to the question "which product do you prefer overall"
Time Frame: On the study day, after dose of each product
Secondary Outcomes
- 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)
- Subject rating for likely compliance with daily dosing,(On the study day, after dose of each product)
Investigators
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