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

NCT01098071 | Completed Phase 4 Results

• 1 other identifier: P04367 - Lebanon
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Adenoids

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Severity of Rhinorrhea at Baseline and Week 12

  Baseline and Week 12

• Severity of Nasal Congestion at Baseline and Week 12

  Baseline and Week 12

• Severity of Nasal Itching at Baseline and Week 12

  Baseline and Week 12

• Severity of Sneezing at Baseline and Week 12

  Baseline and Week 12

• Severity of Eye Symptoms at Baseline and Week 12

  Baseline and Week 12

Study Arms (1)

mometasone furoate nasal spray

EXPERIMENTAL

Drug: mometasone furoate nasal spray

Interventions

mometasone furoate nasal spray DRUG

One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months

Also known as: SCH 32088, Nasonex

mometasone furoate nasal spray

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 23010795 RESULT

MeSH Terms

Interventions

Mometasone Furoate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: August 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 28, 2024
• Results First Posted: November 29, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share