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

Sponsor:	University of Brasilia
Information provided by:	University of Brasilia
ClinicalTrials.gov Identifier:	NCT00770900

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 IV

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

Drug Information available for: Montelukast sodium Montelukast

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 February 09, 2012