A Phase 4 interventional study of montelukast in Lung Disease, Obstructive and Signs and Symptoms, Respiratory, sponsored by University of Helsinki. Completed at 1 site in Finland. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2009-07-08.
Sponsored by University of Helsinki · Phase 4, Interventional, and Treatment
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 112 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
montelukast 4 mg once per day for 8 weeks
Drug: montelukast
montelukast 4mg once per day for 8 weeks period
Also known as: singulair
symptom free days
Time frame: 2 weeks runin and 8 weeks treatment
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
Time frame: before and after 8 weeks treatment
This study is completed, as verified in Oct 2003. You cannot join it, but the record below documents what was studied.
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University of Helsinki