Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)
NCT00770900 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2010-12-20
Summary
Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic in patients with persistent asthma treated with montelukast
Conditions
Interventions
- DRUG
-
montelukast sodium
Asthmatic children and teenagers took montelukast daily for 12 weeks. Children aged 2-5 years took 4mg tablet of montelukast Children aged 6-15 years took 5mg tablet of montelukast Children \>15 years took 10mg tablet of montelukast
- DRUG
-
Comparator: placebo comparator
Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.
Sponsors & Collaborators
-
University of Brasilia
lead OTHER
Principal Investigators
-
Medical Monitor · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2009-12-31
- Completion
- 2009-12-31
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