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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: montelukast sodium; Drug: Comparator: placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients Between 2-18 Years With Persistent Asthma

Exclusion Criteria:

Patients > 18 Years Old And < 2 Years Old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montelukast; Asthmatic children and teenagers took montelukast daily.	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; Other Names: Singulair
Placebo Comparator: Placebo; Placebo to montelukast tablet daily.	Drug: Comparator: placebo comparator; Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic.	12 weeks

Collaborators and Investigators

• Sponsor: University of Brasilia

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (Estimate): October 10, 2008

Study Record Updates

• Last Update Posted (Estimate): December 20, 2010
• Last Update Submitted That Met QC Criteria: December 17, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 2008_563; MK0476-403