Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)

Double Blind, Placebo Controlled Trial, Evaluating the Role of Nasonex® in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00553891

Enrollment

Registered

2007-11-06

Start date

2006-05-31

Completion date

2009-10-31

Last updated

2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoidectomy, Adenoids Hypertrophy, Nasal Obstruction

Brief 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

Interventions

DRUGmometasone furoate nasal spray

One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.

DRUGplacebo nasal spray

One spray in each nostril once daily for 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 11 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	The total duration of therapy is 3 months the follow up period is for 12 months.

Secondary

Measure	Time frame
To identify the characteristics of subjects who will show complete or significant resolution of the nasal obstruction symptoms secondary to enlarged adenoids, upon using Nasonex.	The total duration of therapy is 3 months the follow up period is for 12 months.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026