Lung Disease, Obstructive, Signs and Symptoms, Respiratory
Conditions
Keywords
montelukast, very young children, lung function tests
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 evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.
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-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.
Interventions
DRUGmontelukast
montelukast 4mg once per day for 8 weeks period
Sponsors
Merck Sharp & Dohme LLC
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* at least one physician-diagnosed wheezing episode and history of recurrent cough, dyspnoea and wheeze and successfully performed methacholine challenge test were included.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom free days | 2 weeks runin and 8 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| lung function, airway responsiveness, exhale nitric oxide, use of rescue medication | before and after 8 weeks treatment |
Countries
Finland
Outcome results
None listed