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The Effect of Montelukast Treatment in Wheezy Infants

NCT00934713 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2009-07-08

No results posted yet for this study

Summary

The study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. The secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.

Conditions

  • Lung Disease, Obstructive
  • Signs and Symptoms, Respiratory

Interventions

DRUG

montelukast

montelukast 4mg once per day for 8 weeks period

Sponsors & Collaborators

Principal Investigators

  • Anna S Pelkonen, MD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Finland

Study Locations

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Entities

Companies

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 NCT00934713 on ClinicalTrials.gov