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The Effect of Montelukast Treatment in Wheezy Infants (Montelukast)

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ClinicalTrials.gov Identifier: NCT00934713
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
Merck Sharp & Dohme LLC
Information provided by:
University of Helsinki

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.

Condition or disease Intervention/treatment Phase
Lung Disease, Obstructive Signs and Symptoms, Respiratory Drug: montelukast Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
Study Start Date : September 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
Active Comparator: montelukast
montelukast 4 mg once per day for 8 weeks
Drug: montelukast
montelukast 4mg once per day for 8 weeks period
Other Name: singulair

Primary Outcome Measures :
  1. symptom free days [ Time Frame: 2 weeks runin and 8 weeks treatment ]

Secondary Outcome Measures :
  1. lung function, airway responsiveness, exhale nitric oxide, use of rescue medication [ Time Frame: before and after 8 weeks treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934713

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Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, P.O.Box 160, Finland, FIN-00029 HUS
Sponsors and Collaborators
University of Helsinki
Merck Sharp & Dohme LLC
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Study Chair: Anna S Pelkonen, MD Helsinki University Central Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pelkonen Anna, Helsinki University Central Hospital, P.O.Box 160, FIN-00029, Finland
ClinicalTrials.gov Identifier: NCT00934713    
Other Study ID Numbers: 33902
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: October 2003
Keywords provided by University of Helsinki:
montelukast, very young children, lung function tests
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Signs and Symptoms, Respiratory
Respiratory Tract Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action