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

Condition(s) targeted: Adenoids Hypertrophy

Intervention: Mometasone Furoate nasal spray (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Adenoid/Choana (A/C) Index Grade

Secondary outcome:

Total Severity Symptom Scores: Morning and Evening (AM & PM)

Total Frequency Symptom Scores: AM & PM

Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done

Number of Participants With Otoscopic Results of: Normal or Abnormal

Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation

Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic

Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction

Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance

Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance

Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa

Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa

Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done

Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa

Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa

Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe

Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)

Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)

Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)

Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

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

Starting date: August 2007
Last updated: October 31, 2014