The Effect of Montelukast Treatment in Wheezy Infants
Montelukast
The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
1 other identifier
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedJuly 8, 2009
October 1, 2003
3.6 years
July 7, 2009
July 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
symptom free days
2 weeks runin and 8 weeks treatment
Secondary Outcomes (1)
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
before and after 8 weeks treatment
Study Arms (1)
montelukast
ACTIVE COMPARATORmontelukast 4 mg once per day for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- at least one physician-diagnosed wheezing episode and history of recurrent cough, dyspnoea and wheeze and successfully performed methacholine challenge test were included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Helsinkilead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, P.O.Box 160, FIN-00029 HUS, Finland
Related Publications (1)
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.
PMID: 23060628DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anna S Pelkonen, MD
Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 8, 2009
Study Start
September 1, 2004
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
July 8, 2009
Record last verified: 2003-10