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Study 4 of 29 for search of: | Open Studies | "Adenoids" |
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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00552032 |
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.
Condition | Intervention | Phase |
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Adenoid Hypertrophy |
Drug: Mometasone Furoate nasal spray Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study. |
Estimated Enrollment: | 144 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Mometasone Furoate nasal spray: Experimental
Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily
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Drug: Mometasone Furoate nasal spray
Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks
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Placebo: Placebo Comparator
Placebo nasal spray 1 puff per nostril twice daily
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Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 2 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Susana Suarez, MD - Medical Director, Mexico Country Operations ) |
Study ID Numbers: | P05155 |
Study First Received: | October 31, 2007 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00552032 |
Health Authority: | Mexico: Federal Commission for Protection Against Health Risks |
Efficacy Safety Furoate Mometasone Spray nasal Treatment adenoid hypertrophy |
Children 2 to 11 years Mometasone Furoate Efficacy and safety Children 2 to 11 years |
Pathological Conditions, Anatomical Hypertrophy Mometasone furoate Snoring |
Anti-Inflammatory Agents Therapeutic Uses Anti-Allergic Agents Pharmacologic Actions |