An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis … (NCT00599027) | Clinical Trial Compass
CompletedPhase 3
An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma
51 participantsStarted 2008-05
Plain-language summary
The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.
Who can participate
Age range
18 Years – 75 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:
* Outpatients (≥18 and ≤ 75 years of age) of either sex
* Willingness to participate and comply with procedures by signing a written informed consent
* Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks)
* To qualify at the randomization visit the daily average of the T5SS \[(Morning-time T5SS + Evening-time T5SS)/2\] had to be ≥ 6 in at least 4 days during the 1 week run-in period
* Positive (weal diameter \>3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level \>3.5 U/mL)
* All prior medication washout times had been observed
* Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication
* Negative urine pregnancy test
* Free of any clinically relevant disease that would have interfered with study evaluations
* Able to adhere to the dosing and visit schedules, and agree to record symptom severity scores and use of IMP and rescue medications in a daily diary
Exclusion Criteria:
* Female who was or intended to become pregnant during the study or within 12 weeks after study completion
* Nursing, or intende…
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
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.