A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasa… (NCT03317015) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)
260 participantsStarted 2016-11-30
Plain-language summary
Primary Objective:
* To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic rhinitis).
Secondary Objectives:
* To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with Flixonase® (fluticasone) administered for 28 days by assessment of adverse events reports.
* To evaluate patient and physician satisfaction after 28 days of treatment by 5-point scale.
* To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ).
Who can participate
Age range
18 Years – 50 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:
* Females and males ≥18 and ≤50 years old.
* Patients with previously diagnosed PAR with a positive skin prick test response to an appropriate allergen performed not earlier than 12 months prior to the Screening visit.
* Patients must be clinically symptomatic (rTNSS reflecting symptoms for the previous 24 h ≥8 with two or more symptoms rated as moderate or severe).
* Negative urine pregnancy test during screening before first dose of study medication is administered in women with child-bearing potential.
* Women must use an effective contraceptive method during the study period.
* Patients should be able to understand the study, including risks and adverse events; collaborating with Investigator and proceed according with protocol.
* Signed informed consent form.
Exclusion criteria:
* Compromised ability to provide informed consent.
* Participation in any other clinical study.
* History of severe local reaction(s) or anaphylaxis to skin testing.
* Upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or viral upper respiratory infection within 2 weeks prior to the Screening Visit.
* Subjects who have used any drug (Flixonase or Nasacort) in an investigational protocol 4 weeks prior to the Screening Visit.
* Female subjects who are breast-feeding, pregnant, or intend to become pregnant.
* Patients with nasal abnormalities, including nasal polyps, and marked septum devi…
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
Change from baseline in total nasal symptom score
Timeframe: From baseline (0 day of treatment) to 28th day of treatment