Effect of montelukast on lung function in children younger than 2 years with wheezing. - ND

• Conditions: Recurrent wheezing; MedDRA version: 9.1Level: PTClassification code 10037833Term: Rales

• Registration Number: EUCTR2008-006437-26-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children <2 years aged with recurrent wheezing (>2 during last 6 months) and symptoms at enrollment.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with allergic asthma, chronic respiratory disease, or with severe symptoms requiring hospitalization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if a 4-weeks treatment with montelukast can significantly reduce Rint values.;Secondary Objective: N.A.;Primary end point(s): Changes in Rint values before and after treatment.