Clinical trial NCT00934713: The Effect of Montelukast Treatment in Wheezy Infants
Official title: The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Disease, Obstructive
Signs and Symptoms, Respiratory
Keywords: montelukast, very young children, lung function tests
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-07-08
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: symptom free days
timeFrame: 2 weeks runin and 8 weeks treatment
Secondary outcomes:
measure: lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
timeFrame: before and after 8 weeks treatment
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Skin and Allergy Hospital, Helsinki University Central Hospital
state: P.O.Box 160
Study officials:
affiliation: Helsinki University Central Hospital
name: Anna S Pelkonen, MD
role: STUDY_CHAIR
References:
citation: Pelkonen AS, Malmstrom K, Sarna S, Kajosaari M, Klemola T, Malmberg LP, Makela MJ. The effect of montelukast on respiratory symptoms and lung function in wheezy infants. Eur Respir J. 2013 Mar;41(3):664-70. doi: 10.1183/09031936.00173411. Epub 2012 Jul 12.