The Effect of Montelukast Treatment in Wheezy Infants

Signs and Symptoms, Respiratory Clinical Trial

— Montelukast  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934713
• Other study ID #: 33902
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2009
• Last updated: July 7, 2009
• Start date: September 2004
• Est. completion date: April 2008

Study information

• Verified date: October 2003
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 24 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Disease, Obstructive
• Lung Diseases
• Lung Diseases, Obstructive
• Signs and Symptoms
• Signs and Symptoms, Respiratory

Intervention

Drug:
• montelukast
montelukast 4mg once per day for 8 weeks period

Locations

Country	Name	City	State
Finland	Skin and Allergy Hospital, Helsinki University Central Hospital	Helsinki	P.O.Box 160

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom free days		2 weeks runin and 8 weeks treatment	Yes
Secondary	lung function, airway responsiveness, exhale nitric oxide, use of rescue medication		before and after 8 weeks treatment	Yes