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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00536705
Recruitment Status : Completed
First Posted : September 28, 2007
Last Update Posted : July 27, 2011
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by:
Shanghai Jiao Tong University School of Medicine

Brief Summary:
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 or disease Intervention/treatment
Asthma Drug: montelukast

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.

Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

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

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.

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: The first people's hospital of shanghai, department of pediatric Identifier: NCT00536705     History of Changes
Other Study ID Numbers: #p2192v1
First Posted: September 28, 2007    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: January 2009

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