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Efficacy of Oral Leukotriene in Long Term Therapy of Mild and Moderate Obstructive Sleep Apnea Syndrome in Children

NCT00912171 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-02-15

No results posted yet for this study

Summary

The aim of the project is to evaluate whether therapy with leukotriene may be a valid therapeutic approach in children with adenotonsillar hypertrophy and with mild and moderate obstructive sleep apnea syndrome (OSAS) and to evaluate whether leukotriene is less, equally or more efficient than nasal steroid.

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

DRUG

budesonide (Aircort 50 nasal spray)

50 mcg per nostril once daily for cycles of 21 days with a break of 7 days for 6 months

DRUG

montelukast (Singulair)

Daily administration in 4 mg chewable tablet for children younger than 6 years or in 5 mg tablet for children 6 years and older

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Filippo Bernardi, Professor · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-04-30
Completion
2010-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912171 on ClinicalTrials.gov