- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00934713
The Effect of Montelukast Treatment in Wheezy Infants (Montelukast)
July 7, 2009 updated by: University of Helsinki
The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
P.O.Box 160
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Helsinki, P.O.Box 160, Finland, FIN-00029 HUS
- Skin and Allergy Hospital, Helsinki University Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 2 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: montelukast
montelukast 4 mg once per day for 8 weeks
|
montelukast 4mg once per day for 8 weeks period
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
symptom free days
Time Frame: 2 weeks runin and 8 weeks treatment
|
2 weeks runin and 8 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
Time Frame: before and after 8 weeks treatment
|
before and after 8 weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Anna S Pelkonen, MD, Helsinki University Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (ACTUAL)
April 1, 2008
Study Completion (ACTUAL)
April 1, 2008
Study Registration Dates
First Submitted
July 7, 2009
First Submitted That Met QC Criteria
July 7, 2009
First Posted (ESTIMATE)
July 8, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
July 8, 2009
Last Update Submitted That Met QC Criteria
July 7, 2009
Last Verified
October 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Signs and Symptoms, Respiratory
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- 33902
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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