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Effect of Montelukast on the Expression and Variation of TGF-β for Children With Mild Persistent Asthma
This study is not yet open for participant recruitment.
Verified by Shanghai Jiao Tong University School of Medicine, September 2007
First Received: September 27, 2007   No Changes Posted
Sponsored by: Shanghai Jiao Tong University of Medicine
Information provided by: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT00536705
  Purpose

The aim of this study was to determine the effects of lower dose Montelukast on the expression and variation of TGF-β in induced sputum and T lymphocyte for children with mild persistent Asthma.


Condition Intervention
Asthma
Drug: montelukast

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast sodium Montelukast
U.S. FDA Resources
Study Type: Observational
Study Design: Cross-Sectional, Case Control, Prospective Study

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Study Start Date: September 2007
Estimated Study Completion Date: December 2009
Intervention Details:
    Drug: montelukast
    montelukast 5-mg chewable tablet with matching placebo once daily in the evening at bedtime.The study consisted of a 2-week, single-blind placebo baseline period and a 12-week double-blind, active treatment period
Detailed Description:

The majority pediatric asthma patients in Shanghai are mild persistent asthma. These patients require controller medications every day to achieve and maintain control. Leukotriene receptor antagonist is one of the options which have been recommended to use as a mono controller therapy. Patient satisfaction and compliance was better with montelukast, attributed to oral intake and convenience. Owing to its easy and simple oral once a day administration montelukast was found to be advantageous over ICS. On the other hand, recent studies have shown that there is a considerable degree of airway remodeling in peripheral airways in patients with mild asthma.The new information points out the need for large, long-term studies on the treatment of mild persistent asthma, with an emphasis on exacerbations, remodeling, and the relationship between these outcomes and markers of asthma control. TGF- β participates in the initiation and propagation of inflammatory and immune responses in the airways. The leukotrienes exert their biologic actions by binding to and activating specific receptors. Montelukast, a cysteinyl leukotriene 1 (CysLT1) receptor antagonist, acts on LTC4, LTD4 and LTE4, and, therefore, on airway inflammation and bronchoconstriction. Some results suggest that low dose of Montelukast may modulate the parameters of inflammation and fibrosis.In this study we try to determine the effects of lower dose Montelukast on the expression and variation of TGF-β in induced sputum and T lymphocyte for children with mild persistent Asthma.

Drug in the study provide by MSD. We have done induced sputum procedure in our past study. Reagent can be bought from company.

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 6 to 14 years with a history of physician-diagnosed asthma (at least 3 episodes of asthma symptoms during the previous year, including, but not limited to cough, wheezing, and shortness of breath)

Exclusion Criteria:

  • Patients were not in good health, other than asthma, on the basis of results of medical history, physical examination, and routine laboratory tests.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536705

Contacts
Contact: Hong jianguo, prof 13386259530 hongjianguo@hotmail.com

Sponsors and Collaborators
Shanghai Jiao Tong University of Medicine
Investigators
Principal Investigator: hong jianguo, prof pediatric of shanghai jiantong University
  More Information

No publications provided

Study ID Numbers: #p2192v1
Study First Received: September 27, 2007
Last Updated: September 27, 2007
ClinicalTrials.gov Identifier: NCT00536705     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
asthma
child
TGF-β
Montelukast

Study placed in the following topic categories:
Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Hormones
Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on May 06, 2009