The Effect of Montelukast Treatment in Wheezy Infants

NCT ID: NCT00934713

Last Updated: 2009-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-04-30

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.

Conditions

Lung Disease, Obstructive; Signs and Symptoms, Respiratory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

montelukast

montelukast 4 mg once per day for 8 weeks

Group Type: ACTIVE_COMPARATOR

montelukast

Intervention Type: DRUG

montelukast 4mg once per day for 8 weeks period

Interventions

montelukast

montelukast 4mg once per day for 8 weeks period

Intervention Type: DRUG

Other Intervention Names

singulair

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Helsinki University Central Hospital, P.O.Box 160, FIN-00029, Finland

Principal Investigators

Anna S Pelkonen, MD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Locations

Skin and Allergy Hospital, Helsinki University Central Hospital

Helsinki, P.O.Box 160, Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 23060628 (View on PubMed)

Other Identifiers

33902

Identifier Type: -

Identifier Source: org_study_id