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

NCT ID: NCT00552032

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-01
• Study Completion Date: 2010-01-01

Brief 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.

Conditions

Adenoids Hypertrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mometasone Furoate nasal spray

Group Type: EXPERIMENTAL

Mometasone Furoate nasal spray

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

SCH 032088

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05155

Identifier Type: -

Identifier Source: org_study_id