NCT01818635CompletedNot Applicable
Phase 4 Study of to Investigation the Effect of Montelukast on Behavior Problems in Children With Asthma
Fatih University2 sites in 1 country600 target enrollmentStarted: March 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- To investigate the effect of montelukast on behavior problems in children with asthma
Study Overview
Brief Summary
The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Months to 60 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •To have asthmatic children aged 18-60 months
- •To have that receive prophylactic treatment for asthma
- •Healthy children will be enrolled among those being brought for routine controls
Exclusion Criteria
- •Children with other chronic disease
- •Children with chronic drug use (except for the treatment of asthma)
Outcomes
Primary Outcomes
To investigate the effect of montelukast on behavior problems in children with asthma
Time Frame: 8 months
Montelukast frequently used in the treatment of asthmatic children. However, we believe that montelukast lead to behavior problems. In this study, we aimed to investigate that intake of montelukast whether lead to behavior problems.
Secondary Outcomes
- To compare the effects of inhaled corticosteroids and montelukast on the behavior problems.(8 months)
Investigators
Ahmet Z. Akelma
Fatih University Medical School
Fatih University
Study Sites (2)
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