CompletedPhase 4

Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)

34 participantsStarted 2008-08-01

Plain-language summary

To document the short term \& long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause \> 50% obstruction of the posterior choanae).

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: * 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy \> 50% of posterior choanae. Exclusion Criteria: * adenoids hypertrophy \< 50% of posterior choanae recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

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

Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score

Timeframe: Baseline and Week 12

Degree of Posterior Choana Obstruction at Baseline and Week 12

Timeframe: Baseline and Week 12

Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT01098071

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09-01

Results submitted2011-06-13

View on ClinicalTrials.gov More Adenoids trials

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.

What they're measuring

Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score

Timeframe: Baseline and Week 12

Degree of Posterior Choana Obstruction at Baseline and Week 12

Timeframe: Baseline and Week 12

Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy

Timeframe: Baseline to 12 weeks