Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, P.O.Box 160, FIN-00029 HUS, Finland
NCT Number: NCT00934713
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.
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Notify Me6 month–24 month
All sexes
Interventional
Phase 4
Helsinki, P.O.Box 160, FIN-00029 HUS, Finland
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-controlled study of 6 to 24 months old children, who had at least one physician-diagnosed wheezing episode and persistent asthmatic symptoms. Patients were randomised to placebo or montelukast 4 mg / day for 8 weeks period. The clinical response to treatment was determined, the functional residual capacity (FRC) and specific air-way conductance (sGaw) was measured using an infant whole-body pletys-mograph, the maximal flow at functional residual capacity (V´maxFRC) was re-corded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric methacholine challenge test.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
montelukast 4mg once per day for 8 weeks period
Other names: singulair
Time frame: 2 weeks runin and 8 weeks treatment
Time frame: before and after 8 weeks treatment
University of Helsinki
Other
The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
Acronym: Montelukast
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