Placebo-Controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nasal Obstruction Adenoids Hypertrophy Adenoidectomy	Drug: mometasone furoate nasal spray Drug: placebo nasal spray	Phase IV

MedlinePlus related topics:

Tonsils and Adenoids

ChemIDplus related topics:

Mometasone furoate Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

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

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

Further study details as provided by Schering-Plough:

Primary Outcome 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome 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. ] [ Designated as safety issue: Yes ]
Serious AEs [ Time Frame: The total duration of therapy is 3 months the follow up period is for 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	285
Study Start Date:	May 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nasonex Nasal Spray: Experimental	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: Placebo Comparator	Drug: placebo nasal spray One spray in each nostril once daily for 3 months.

Eligibility

Ages Eligible for Study:	2 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553891

Contacts


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

Locations


Lebanon
	Investigational Site 1	Recruiting
	Beirut, Lebanon

Sponsors and Collaborators

Schering-Plough

Investigators


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

Principal Investigator:	Rouwayda Dana, MD	Schering-Plough Levant

More Information

Responsible Party:	Schering-Plough ( Rouwayda Dana, Levant Country Operations )
Study ID Numbers:	P04367, PV-04367; SCH 032088
First Received:	November 5, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00553891
Health Authority:	Lebanon: Institutional Review Board

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Hypertrophy

Otorhinolaryngologic Diseases

Respiratory Insufficiency

Nasal Obstruction

Respiratory Tract Diseases

Mometasone furoate

Salicylsalicylic acid

Respiration Disorders

Sodium Salicylate

Neoplasm Metastasis

Airway Obstruction

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00553891