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

This study has been completed.
Information provided by:
University of Brasilia Identifier:
First received: October 9, 2008
Last updated: December 17, 2010
Last verified: January 2010
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

Condition Intervention Phase
Drug: montelukast sodium
Drug: Comparator: placebo comparator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Study to Evaluate the Eosinophils Activation Parameters and Phagocyte Function in Patients With Persistent Asthma Treated With Montelukast

Resource links provided by NLM:

Further study details as provided by University of Brasilia:

Primary Outcome Measures:
  • 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 ]

Enrollment: 83
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Singulair
Placebo Comparator: Placebo
Placebo to montelukast tablet daily.
Drug: Comparator: placebo comparator
Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients Between 2-18 Years With Persistent Asthma

Exclusion Criteria:

Patients > 18 Years Old And < 2 Years Old

  Contacts and Locations
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Please refer to this study by its identifier: NCT00770900

Sponsors and Collaborators
University of Brasilia
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp Identifier: NCT00770900     History of Changes
Other Study ID Numbers: 2008_563
Study First Received: October 9, 2008
Last Updated: December 17, 2010

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017