The Effect of Montelukast Treatment in Wheezy Infants (Montelukast)
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| ClinicalTrials.gov Identifier: NCT00934713 |
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Recruitment Status :
Completed
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
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Sponsor:
University of Helsinki
Collaborator:
Merck Sharp & Dohme LLC
Information provided by:
University of Helsinki
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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 |
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 (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 |
|---|---|
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Active Comparator: montelukast
montelukast 4 mg once per day for 8 weeks
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Drug: montelukast
montelukast 4mg once per day for 8 weeks period
Other Name: singulair |
Primary Outcome Measures :
- symptom free days [ Time Frame: 2 weeks runin and 8 weeks treatment ]
Secondary Outcome Measures :
- lung function, airway responsiveness, exhale nitric oxide, use of rescue medication [ Time Frame: before and after 8 weeks treatment ]
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| Ages Eligible for Study: | 6 Months to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
Locations
| Finland | |
| 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
Investigators
| Study Chair: | Anna S Pelkonen, MD | Helsinki University Central Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 Montelukast 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 |