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NCT00770900 Clinical Trial

Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)

Asthma Clinical Trial

Official title:
Prospective, Randomized, Double-blind, Study to Evaluate the Eosinophils Activation Parameters and Phagocyte Function in Patients With Persistent Asthma Treated With Montelukast

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00770900
Other study ID # 2008_563
Secondary ID MK0476-403
Status Completed
Phase Phase 4
First received October 9, 2008
Last updated December 17, 2010
Start date September 2008
Est. completion date December 2009

Study information
Verified date January 2010
Source University of Brasilia
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

Patients Between 2-18 Years With Persistent Asthma

Exclusion Criteria:

Patients > 18 Years Old And < 2 Years Old

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• Comparator: placebo comparator
Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Brasilia

Outcome
Type Measure Description Time frame Safety issue
Primary Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic. 12 weeks No
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