Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367) (NAHCh)

Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

To document the short term & long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the posterior choanae).

Study Overview

• Status: Completed
• Conditions: Adenoids
• Intervention / Treatment: Drug: mometasone furoate nasal spray

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Exclusion Criteria:

• adenoids hypertrophy < 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mometasone furoate nasal spray	Drug: mometasone furoate nasal spray; One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months; Other Names: SCH 32088; Nasonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score	Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).	Baseline and Week 12
Degree of Posterior Choana Obstruction at Baseline and Week 12	The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.	Baseline and Week 12
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy		Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Rhinorrhea at Baseline and Week 12	Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).	Baseline and Week 12
Severity of Nasal Congestion at Baseline and Week 12	Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).	Baseline and Week 12
Severity of Nasal Itching at Baseline and Week 12	Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).	Baseline and Week 12
Severity of Sneezing at Baseline and Week 12	Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).	Baseline and Week 12
Severity of Eye Symptoms at Baseline and Week 12	Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Bitar MA, Mahfoud L, Nassar J, Dana R. Exploring the characteristics of children with obstructive adenoid responding to mometasone fuorate monohydrate: preliminary results. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):931-7. doi: 10.1007/s00405-012-2155-8. Epub 2012 Aug 22.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: April 1, 2010
• First Submitted That Met QC Criteria: April 1, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P04367 - Lebanon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No