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Completed

NCT Number: NCT00934713

The Effect of Montelukast Treatment in Wheezy Infants

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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Key information

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skin and Allergy Hospital, Helsinki University Central Hospital

Helsinki, P.O.Box 160, FIN-00029 HUS, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Montelukast

Drug

montelukast 4mg once per day for 8 weeks period

Other names: singulair

Primary outcomes

  1. symptom free days

    Time frame: 2 weeks runin and 8 weeks treatment

Secondary outcomes

  1. lung function, airway responsiveness, exhale nitric oxide, use of rescue medication

    Time frame: before and after 8 weeks treatment

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children

Acronym: Montelukast

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jul 8, 2009
Registry last updated
Jul 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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