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

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 (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in children.

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. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
• Drug: Placebo
  • Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Mometasone Furoate nasal spray
• Placebo Comparator: Placebo

Primary Measures

• Change From Baseline in Adenoid/Choana (A/C) Index Grade
  • Time Frame: Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)
    Safety Issue?: No

Secondary Measures

• Total Severity Symptom Scores: Morning and Evening (AM & PM)
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Total Frequency Symptom Scores: AM & PM
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Number of Participants With Otoscopic Results of: Normal or Abnormal
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No
• Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
  • Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
    Safety Issue?: No

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 accomplished the designated washout periods for any of the prohibited medications
• Participants who have used any investigational products within the last 30 days
• Participants who have used any antibodies for allergies in the past 90 days
• Participants who have any abnormal physical examination results that may affect study evaluations or participant safety in the investigator's judgment
• Participants who are allergic or have an idiosyncratic reaction to corticosteroids
• Participants with signs and symptoms of acute or chronic bacterial rhinosinusitis
• Participants 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
• Participants with a documented immunodeficiency condition
• Participants with nasal structural abnormalities, including large nasal polyps and marked septum deviation that significantly interferes with nasal airflow
• Participants 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 participant 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 Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

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