Original Primary Outcome: 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) ]

Current Secondary Outcome:

• Total Severity Symptom Scores: Morning and Evening (AM & PM) [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]
  Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM & PM (a difference of 12 hours) & were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.
• Total Frequency Symptom Scores: AM & PM [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]
  Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM & PM (a difference of 12 hours) & were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.
• 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) ]
  Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).
• Number of Participants With Otoscopic Results of: Normal or Abnormal [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]
  Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).
• 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) ]
  Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.
• 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) ]
  Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).
• 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) ]
  Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).
• Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

  Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.

  Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec).

• Rhinomanometry Results- Left and Right Nasal Fossa: E
  
  

  Original Secondary Outcome:

  • 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 ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Improvement in the Otoscopic and Rhinoscopic examination. [ Time Frame: Between Baseline and end of treatment (week 8) ]
  • 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) ]
  • Adverse events (related and concurrent) incidence. [ Time Frame: 8 week treatment period followed by 16 week follow-up ]
  • Incidence of adenoid hypertrophy recurrence during blinded follow-up extension period via Nasopharyngoscopic evaluation every 2 months. [ Time Frame: Every 2 months ]
  
  
  Information By: Merck Sharp & Dohme Corp.
  

  Dates:
  Date Received: October 31, 2007
  Date Started: August 1, 2007
  Date Completion:
  Last Updated: March 24, 2017
  Last Verified: March 2017