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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-01

Study Completion Date

2009-09-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Adenoids

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mometasone furoate nasal spray

Group Type EXPERIMENTAL

mometasone furoate nasal spray

Intervention Type DRUG

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

Interventions

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mometasone furoate nasal spray

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

Intervention Type DRUG

Other Intervention Names

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SCH 32088 Nasonex

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No