Asthma, Behavior Problem, Montelukast Clinical Trial
Official title:
Phase 4 Study of to Investigation the Effect of Montelukast on Behavior Problems in Children With Asthma
The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Months to 60 Months |
| Eligibility |
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) |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Fatih University | Ankara | |
| Turkey | Fatih University Medical School | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Fatih University | Kecioren Teaching and Research Hospital |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To investigate the effect of montelukast on behavior problems in children with asthma | 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. | 8 months | Yes |
| Secondary | To compare the effects of inhaled corticosteroids and montelukast on the behavior problems. | In this study, it will be compared the effect on behavior changes between intake of inhaled steroid and montelukast. | 8 months | Yes |