Back to resultsThe Effect of Montelukast Treatment in Wheezy Infants (Montelukast)
Primary Purpose
Lung Disease, Obstructive, Signs and Symptoms, Respiratory
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
montelukast
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease, Obstructive focused on measuring montelukast, very young children, lung function tests
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.
Sites / Locations
- Skin and Allergy Hospital, Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
montelukast
Arm Description
montelukast 4 mg once per day for 8 weeks
Outcomes
Primary Outcome Measures
symptom free days
Secondary Outcome Measures
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
Full Information
NCT ID
NCT00934713
First Posted
July 7, 2009
Last Updated
July 7, 2009
Sponsor
University of Helsinki
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00934713
Brief Title
The Effect of Montelukast Treatment in Wheezy Infants
Acronym
Montelukast
Official Title
The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2003
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Helsinki
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease, Obstructive, Signs and Symptoms, Respiratory
Keywords
montelukast, very young children, lung function tests
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
montelukast
Arm Type
Active Comparator
Arm Description
montelukast 4 mg once per day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
montelukast
Other Intervention Name(s)
singulair
Intervention Description
montelukast 4mg once per day for 8 weeks period
Primary Outcome Measure Information:
Title
symptom free days
Time Frame
2 weeks runin and 8 weeks treatment
Secondary Outcome Measure Information:
Title
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
Time Frame
before and after 8 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna S Pelkonen, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Skin and Allergy Hospital, Helsinki University Central Hospital
City
Helsinki
State/Province
P.O.Box 160
ZIP/Postal Code
FIN-00029 HUS
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23060628
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.
Results Reference
derived
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The Effect of Montelukast Treatment in Wheezy Infants
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