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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenoids

Intervention: mometasone furoate nasal spray (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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).

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score

Degree of Posterior Choana Obstruction at Baseline and Week 12

Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy

Secondary outcome:

Severity of Rhinorrhea at Baseline and Week 12

Severity of Nasal Congestion at Baseline and Week 12

Severity of Nasal Itching at Baseline and Week 12

Severity of Sneezing at Baseline and Week 12

Severity of Eye Symptoms at Baseline and Week 12

Eligibility

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: August 2008
Last updated: October 30, 2014

Page last updated: August 23, 2015

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