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

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

Completed

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients Between 2-18 Years With Persistent Asthma

Exclusion criteria

Patients > 18 Years Old And < 2 Years Old

Treatment and study plan

montelukast sodium

Drug

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

Other names: Singulair

Comparator: placebo comparator

Drug

Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.

Primary outcomes

Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic.

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 10, 2008
Registry last updated: Dec 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed