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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.
Sponsor:
Information provided by:
University of Brasilia
ClinicalTrials.gov Identifier:
NCT00770900
First received: October 9, 2008
Last updated: December 17, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Asthma
 Drug: montelukast sodium
Drug: Comparator: placebo comparator
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients Between 2-18 Years With Persistent Asthma

Exclusion Criteria:

Patients > 18 Years Old And < 2 Years Old

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

Sponsors and Collaborators
University of Brasilia
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00770900     History of Changes
Other Study ID Numbers: 2008_563, MK0476-403
Study First Received: October 9, 2008
Last Updated: December 17, 2010
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013