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

Nasal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00553891
• Other study ID #: P04367
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2006
• Est. completion date: October 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoidectomy
• Adenoids Hypertrophy
• Hypertrophy
• Nasal Obstruction

Intervention

Drug:
• mometasone furoate nasal spray
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.
• placebo nasal spray
One spray in each nostril once daily for 3 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.