Clinical trial

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

Name

P04367 - Lebanon

Description

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).

Trial arms

Trial start

2008-08-01

Estimated PCD

2009-09-01

Trial end

2009-09-01

Status

Completed

Phase

Early phase I

Treatment

mometasone furoate nasal spray

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

Arms:

mometasone furoate nasal spray

Other names:

SCH 32088, Nasonex

Size

Primary endpoint

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

Baseline and Week 12

Degree of Posterior Choana Obstruction at Baseline and Week 12

Baseline and Week 12

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

Baseline to 12 weeks

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

Updated at

2024-05-28

1 organization

1 product

1 indication

Organization

Organon and Co

Product

Mometasone furoate

Indication

Adenoid hypertrophy