Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (Study P05155)(COMPLETED)
Summary
The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate nasal spray, twice daily, is safe and effective in treating adenoid hypertrophy in children.
Description
The tonsils are part of Waldeyer's ring, the basic function of which is antibody formation; they react later against a wide variety of antigens. Allergic sensitization of the airways occurs not only in the mucosa of the afflicted organ, but also in the lymphatic stations draining these structures. The lymphatic structures closest to the nasal mucosa in humans are the adenoids and tonsils. Adenoidal, nasal, and middle ear diseases are frequent health problems in young children and an important cause of impairment on the quality of life of these children. Pediatric adenoidal obstruction of the nasal airway is associated with significant morbidity and is also a frequent indication for surgery. Research shows that allergy and sensitivity to different kinds of allergens are risk factors for adenoid hypertrophy (AH) in children. Histopathological and immunohistochemical studies confirm that tonsil dendritic cells, macrophages, eosinophils, and mast cells are involved in and are important in tonsillitis.
Adenoid hypertrophy is one of the most prevalent causes of snoring and obstructive sleep disorders in children, atopic or non atopic. Surgery is a very common indication for these children. There are very few well controlled clinical trials that have evaluated the efficacy and safety of nasal steroids to treat adenoid hypertrophy. Treatment with steroids has been related with decrease of adenoid size, improvement in physical characteristics of tubal secretions and with symptoms improvement.
Comparisons: Two months treatment with Mometasone Furoate Nasal Spray 1 puff (50 mcg) in each nostril twice daily compared to placebo nasal spray in children 2 to 11 years of age.
The study will include a 16-week follow-up period of observation to determine the incidence of adenoid hypertrophy recurrence in all patients.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Adenoid Hypertrophy
Intervention
Mometasone Furoate nasal spray, Placebo
Status
Completed
Source
Schering-Plough
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00552032
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Nasal Sprays
Agents delivered into the nostrils in the form of a mist or spray.
Carbocysteine
A compound formed when iodoacetic acid reacts with sulfhydryl groups in proteins. It has been used as an anti-infective nasal spray with mucolytic and expectorant action.
Nasal Lavage Fluid
Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.
Nasal Cavity
The proximal portion of the respiratory passages on either side of the NASAL SEPTUM. Nasal cavities, extending from the nares to the NASOPHARYNX, are lined with ciliated NASAL MUCOSA.
Nasal Provocation Tests
Application of allergens to the nasal mucosa. Interpretation includes observation of nasal symptoms, rhinoscopy, and rhinomanometry. Nasal provocation tests are used in the diagnosis of nasal hypersensitivity, including RHINITIS, ALLERGIC, SEASONAL.
Clinical Trials
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