Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scent… (NCT00817050) | Clinical Trial Compass
CompletedPhase 4
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)
100 participantsStarted 2004-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall product preference based on subjects' answer to the question "which product do you prefer overall"
Timeframe: On the study day, after dose of each product