Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in … (NCT00553891) | Clinical Trial Compass
WithdrawnPhase 4
Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)
Stopped: No enrollment because of war in the study country.
0Started 2006-05
Plain-language summary
This is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will be followed starting first dose-till 30 days after study treatment period completion.
This study was terminated - Please see "P04367 - Lebanon"
Who can participate
Age range
2 Years – 11 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:
* Should be between 2 and 11 years.
* Should have nasal obstruction for at least 3 months.
* Should have evidence of adenoids hypertrophy by nasopharyngoscopy, which cause \>50% obstruction of the posterior choanae.
* May have concomitant allergic rhinitis, by history, \& and specific blood studies; however, the symptoms should be under control during the study period.
Exclusion Criteria:
* Patients with less than 50% obstruction of the post choanae.
* Patients with history of recurrent epistaxis or immunodeficiency.
* Patients with severe septal deviation.
* Patients with unilateral or bilateral choanal atresia, large nasal polyps or any nasal mass.
* Known allergy to the drug.
* Presence of chronic otitis media defined as: otorreha + perforation (concomitant otitis media with effusion, or recurrent otitis media are not excluded).
* Cystic fibrosis \& other causes responsible for nasal obstruction.
* Infection (ie; sinusitis).
* History of recent surgery or trauma to nose, unless all wounds have healed.
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
To document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen.
Timeframe: The total duration of therapy is 3 months the follow up period is for 12 months.