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Sponsored by: |
Shanghai Jiao Tong University of Medicine |
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Information provided by: | Shanghai Jiao Tong University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00536705 |
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 |
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Asthma |
Drug: montelukast |
Study Type: | Observational |
Study Design: | Cross-Sectional, Case Control, Prospective Study |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2009 |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hong jianguo, prof | 13386259530 | hongjianguo@hotmail.com |
Principal Investigator: | hong jianguo, prof | pediatric of shanghai jiantong University |
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 |
asthma child TGF-β Montelukast |
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 |
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 |