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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006437-26-IT
Enrollment
Unknown
Registered
2008-11-19
Start date
2008-06-03
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent wheezing MedDRA version: 9.1 Level: PT Classification code 10037833 Term: Rales

Interventions

Pharmaceutical Form: Chewable tablet INN or Proposed INN: Montelukast Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4-

Sponsors

AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children 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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026