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

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"

Study Overview

• Status: Withdrawn
• Conditions: Nasal Obstruction; Adenoidectomy; Adenoids Hypertrophy
• Intervention / Treatment: Drug: mometasone furoate nasal spray; Drug: placebo nasal spray

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasonex Nasal Spray	Drug: mometasone furoate nasal spray; One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.; Other Names: SCH 32088; Nasonex
Placebo Comparator: Placebo Nasal Spray	Drug: placebo nasal spray; One spray in each nostril once daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: November 5, 2007
• First Submitted That Met QC Criteria: November 5, 2007
• First Posted (Estimate): November 6, 2007

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Hypertrophy; Nasal Obstruction; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P04367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No