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Effect of Montelukast on the Expression and Variation of TGF-β for Children With Mild Persistent Asthma

This study has been completed.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by:
Shanghai Jiao Tong University School of Medicine Identifier:
First received: September 27, 2007
Last updated: July 26, 2011
Last verified: January 2009
The Objective of our research is to observe the effect of cysteinyl leukotriene receptor antagonist on the expression and variation of TGF-β1 levels and mRNA expression in children with mild persistent asthma in their plasma and T lymphocyte, to discuss the role of TGF-β1 in the pathogenesis of bronchial asthma in children and to evaluate the function of regulation of leukotriene receptor antagonist on asthma in children.

Condition Intervention
Drug: montelukast

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

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

Biospecimen Retention:   Samples Without DNA
Subjects inhaled hypertonic saline (3%) via an ultrasonic nebulizer with the output set at maximum for 20 minutes. To collect sputum, subjects were asked to expectorate the sputum onto a plastic Petri dish after the 20-min period of inhalation. During the inducing procedure, macroscopic characteristics of the sputum were recorded and adequate plugs of sputum were separated from saliva and processed immediately after expectoration.The complete blood count, platelet count, and serum biochemical analyses were done meanwhile.

Enrollment: 112
Study Start Date: January 2009
Study Completion Date: March 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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
    Other Name: singulair
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.


Ages Eligible for Study:   6 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
After screening 200 patients, we randomized 120 patients aged 6 to 14 years with a history of physician-diagnosed asthma .These patients randomized into montelukast group and placebo group.

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.
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Please refer to this study by its identifier: NCT00536705

China, Shanghai
Shanghai First People'S Hospital
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Principal Investigator: hong jianguo, prof pediatric of shanghai jiantong University
  More Information

Responsible Party: The first people's hospital of shanghai, department of pediatric Identifier: NCT00536705     History of Changes
Other Study ID Numbers: #p2192v1 
Study First Received: September 27, 2007
Last Updated: July 26, 2011
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
transforming growth factor beta(TGF-β)
Leukotriene Antagonists(Montelukast)

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 October 25, 2016