Primary Outcome Measures:
- Size reduction of the adenoids from Baseline as graded by Nasopharyngoscopic evaluation (Adenoid/Choana A/C Index) [ Time Frame: Between Baseline and end of treatment (week 8) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement in AM and PM Symptoms Score (snoring, nasal obstruction, oral breathing, ear pain, nasal discharge and difficulty breathing) as evaluated by the parent or patient. [ Time Frame: 8 week treatment period followed by 16 week follow-up ] [ Designated as safety issue: No ]
- Improvement in the Rhinomanometry, Pure Tone Audiogram and Acoustic Rhinometry measurements in children ages 7 to 11 years old from baseline to end of treatment (week 8) and end of follow up (week 24). [ Time Frame: From baseline to end of treatment (week 8) and end of follow up (week 24) ] [ Designated as safety issue: No ]
- Pediatric Sleep Questionnaire (PSQ, Spanish) improvement from baseline to end of treatment (week 8) and end of follow up (week 24). [ Time Frame: From baseline to end of treatment (week 8) and end of follow up (week 24) ] [ Designated as safety issue: No ]
- Pediatric QOL Questionnaire (PedsQL, Spanish) and Pediatric OSA-18 improvement from baseline to end of treatment (week 8) and end of follow up (week 24). [ Time Frame: From baseline to end of treatment (week 8) and end of follow up (week 24) ] [ Designated as safety issue: No ]
- Improvement in the Otoscopic and Rhinoscopic examination. [ Time Frame: Between Baseline and end of treatment (week 8) ] [ Designated as safety issue: No ]
- Improvement in measures of Bilateral Tympanogram in children 2 to 11 years old from baseline to end of treatment (week 8) and end of follow up (week 24). [ Time Frame: From baseline to end of treatment (week 8) and end of follow up (week 24) ] [ Designated as safety issue: No ]
- Adverse events (related and concurrent) incidence. [ Time Frame: 8 week treatment period followed by 16 week follow-up ] [ Designated as safety issue: Yes ]
- Incidence of adenoid hypertrophy recurrence during blinded follow-up extension period via Nasopharyngoscopic evaluation every 2 months. [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
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.