Status:
COMPLETED
The Effect of Montelukast Treatment in Wheezy Infants
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Lung Disease, Obstructive
Signs and Symptoms, Respiratory
Eligibility:
All Genders
6-24 years
Phase:
PHASE4
Brief 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 e...
Detailed Description
The aim of this study was to investigate the effectiveness of montelukast in wheezy very young children with persistent respiratory symptoms. This study was a prospective, double-blind, placebo-contro...
Eligibility Criteria
Inclusion
- at least one physician-diagnosed wheezing episode and history of recurrent cough, dyspnoea and wheeze and successfully performed methacholine challenge test were included.
Exclusion
- use of ICS within 8 weeks prior to the first visit, a cumulative life-time systemic prednisolone use more than 3 days at a dose of 2 mg/kg, an equipotent dose of another systemic corticosteroid or ICS use more than 4 weeks, respiratory infection in the 14 days preceding lung function measurement and obvious tracheobronchomalacia or other structural defect.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00934713
Start Date
September 1 2004
End Date
April 1 2008
Last Update
July 8 2009
Active Locations (1)
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1
Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, P.O.Box 160, Finland, FIN-00029 HUS