Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (Study P05155)(COMPLETED)
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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Mometasone Furoate nasal spray, Placebo
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00552032
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Agents delivered into the nostrils in the form of a mist or spray.
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.
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.
The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in...
This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine t...
This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing t...
This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of...
This study will compare the safety and efficacy of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test...
Aim of this work is to find out whether the symptoms attributable to adenoid hypertrophy in adolescents may be treated with intranasal mometasone furoate (MF) application. To learn if adenoid hypertro...
Abstract Conclusion: Power-assisted turbinectomy is a safe and reliable alternative for patients with nasal blockage if nasal corticosteroid spray therapy is not suitable. Objective: Powered-assisted...
To cite this article: Bielory L, Chun Y, Bielory BP, Canonica GW. Impact of mometasone furoate nasal spray on individual ocular symptoms of allergic rhinitis: a meta-analysis. Allergy 2011; DOI: 10.11...
Background: Allergic rhinitis (AR) affects up to 40% of children by age 6 years. Perennial AR (PAR) causes sleep disturbance, diminishes concentration in school, impairs psychosocial functioning, and...
Introduction: Asthma is a chronic inflammatory disease that causes significant morbidity and mortality. Inhaled corticosteroids are the preferred initial treatment for this disorder. Mometasone furoa...