Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)
Condition: Adenoids Hypertrophy
MeSH terms: Hypertrophy
Intervention: Mometasone Furoate nasal spray; Placebo
Intervention description: 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).; 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).
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 132.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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