Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)

Inclusion Criteria: * Participants and their parents must demonstrate willingness to participate and comply with study procedures. Parents must sign a written informed consent * Participants and their parents must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, medication times, and concomitant medications accurately and consistently in a daily diary * Children with a history of adenoid hypertrophy for at least 3 months with no response to previous medical treatment * Baseline adenoid tissue size must have been graded by nasopharyngoscopy examination as Grade III or IV on the Adenoid/Choana (A/C) Index (between 50% and 100% obstruction) * Baseline Total Severity Symptoms Score must be ≥ 8 points (AM or PM) * For inclusion in endpoints relating to otitis media with effusion (OME), participant must have persistent middle ear effusion for the past 3 months or more documented by otoscopic examination, middle ear pressure less than -150 mm H2O, Jerger type B flat tympanogram, and mild-moderate conductive hearing loss in audiometry supporting the diagnosis of OME Exclusion Criteria: * Participants with previous surgery of hypertrophic adenoids with or without tympanostomy tube placement * Participants treated with inhaled or systemic corticosteroids within the past 1 month * Participants with Morbid Obesity (Body Mass Index \>95 percentile of charts from the Centers for Disease Control) * Participants who have not acco…