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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Mometasone Furoate nasal spray
  • Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Mometasone Furoate nasal spray
  • Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily
• Placebo Comparator: Placebo
  • Placebo nasal spray 1 puff per nostril twice daily

Primary 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)
    Safety Issue?: No

Secondary 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
    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)
    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)
    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)
    Safety Issue?: No
• Improvement in the Otoscopic and Rhinoscopic examination.
  • Time Frame: Between Baseline and end of treatment (week 8)
    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)
    Safety Issue?: No
• Adverse events (related and concurrent) incidence.
  • Time Frame: 8 week treatment period followed by 16 week follow-up
    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
    Safety Issue?: No

Inclusion Criteria:

• Subjects and their parents must demonstrate willingness to participate and comply with study procedures. Parents must sign a written informed consent.
• Children 2 to 11 years old of both gender.
• Subjects 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), subject 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:

• Subjects with previous surgery of hypertrophic adenoids with or without tympanostomy tube placement.
• Subjects treatmented with inhaled or systemic corticosteroids within the past 1 month.
• Subject with Morbid Obesity (Body Mass Index >95 percentile of charts from the Centers for Disease Control).
• Subjects who have not accomplished the designated washout periods for any of the prohibited medications.
• Subjects who have used any investigational products within the last 30 days
• Subjects who have used any antibodies for allergies in the past 90 days.
• Subjects who have any abnormal physical examination results that may affect study evaluations or subject safety in the investigator's judgment.
• Subjects who are allergic or have an idiosyncratic reaction to corticosteroids.
• Subjects with signs and symptoms of acute or chronic bacterial rhinosinusitis.
• Subject has had an upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose later than 14 days prior to screening, or who has had a viral upper or lower respiratory infection within 7 days prior to screening.
• Subjects with a documented immunodeficiency condition.
• Subjects with nasal structural abnormalities, including large nasal polyps and marked septum deviation that significantly interferes with nasal airflow.
• Subjects with any clinically significant metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Overall Clinical Trial Officials and Contacts

Overall Contact: SP Clinical Trial Registry Call Center 1-888-772-8734 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00552032

Study ID Number: P05155

ClinicalTrials.gov Identifier: NCT00552032

Health Authority: Mexico: Federal Commission for Protection Against Health Risks