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

NCT00553891 | Withdrawn Phase 4

• 1 other identifier: P04367
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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"

Conditions

Nasal Obstruction; Adenoids Hypertrophy; Adenoidectomy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• 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.

Study Arms (2)

Nasonex Nasal Spray

EXPERIMENTAL

Drug: mometasone furoate nasal spray

Placebo Nasal Spray

PLACEBO COMPARATOR

Drug: placebo nasal spray

Interventions

mometasone furoate nasal spray DRUG

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

Also known as: SCH 32088, Nasonex

Nasonex Nasal Spray

placebo nasal spray DRUG

One spray in each nostril once daily for 3 months.

Placebo Nasal Spray

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: May 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 18, 2022

Record last verified: 2022-02