Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Nasonex Nasal Spray
• Placebo Comparator: Placebo Nasal Spray

Primary Measures

• 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.
  • Time Frame: The total duration of therapy is 3 months the follow up period is for 12 months.
    Safety Issue?: Yes

Secondary Measures

• 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.
  • Time Frame: The total duration of therapy is 3 months the follow up period is for 12 months.
    Safety Issue?: Yes
• Serious AEs
  • Time Frame: The total duration of therapy is 3 months the follow up period is for 12 months.
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Overall Clinical Trial Officials and Contacts

Mohammed Bitar, MD Principal Investigator American University of Beirut, Medical Center AUB-MC  

Overall Contact: SP Clinical Trial Registry Call Center 1-888-772-8734 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00553891

Study ID Number: P04367

ClinicalTrials.gov Identifier: NCT00553891

Health Authority: Lebanon: Institutional Review Board