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

NCT00552032 | Completed Phase 3 Results

• 1 other identifier: P05155
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Adenoid/Choana (A/C) Index Grade

  Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.

  Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)

Secondary Outcomes (19)

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

  Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)

• Total Frequency Symptom Scores: AM & PM

  Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)

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

  Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)

• Number of Participants With Otoscopic Results of: Normal or Abnormal

  Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)

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

  Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)

Study Arms (2)

Mometasone Furoate nasal spray

EXPERIMENTAL

Drug: Mometasone Furoate nasal spray

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mometasone Furoate nasal spray 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).

Also known as: SCH 032088

Mometasone Furoate nasal spray

Placebo 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).

Placebo

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Limitations and Caveats

The results of this study as presented are drawn from the clinical study report and should be reviewed with caution as there were inaccuracies in the database resulting from medication errors in some participants.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 20, 2024
• Results First Posted: January 31, 2012

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share