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

NCT00536705 | Completed

• 1 other identifier: #p2192v1
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; child; transforming growth factor beta(TGF-β); Leukotriene Antagonists(Montelukast)

Interventions

montelukast DRUG

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

Also known as: singulair

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Patients were not in good health, other than asthma, on the basis of results of medical history, physical examination, and routine laboratory tests.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai First People'S Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

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.

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• hong jianguo, prof

  pediatric of shanghai jiantong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: March 1, 2011
• Last Updated: July 27, 2011

Record last verified: 2009-01

Locations

CN (1)