Effects of Montelukast on Airway Regulatory T Cells in Asthma
- Registration Number
- NCT01951898
- Lead Sponsor
- Kurume University
- Brief Summary
Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- asthma
- mild status
- stable status
- nonsmoker
- Positive of airway hyperresponsiveness (Methacholine-PC20<16mg/mL)
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Exclusion Criteria
- taken other asthmatic medications such as oral, injective, and inhaled steroids, leukotriene antagonists, oral, inhaled, and transdermal beta-agonists, theophylline, anti-histamine agents, anti-IgE antibodies and long acting muscarinic receptor antagonists.
- respiratory tract infections within 4wks
- moderate to severe other organ disorders
- active malignancies
- past histories of side effects of leukotriene antagonists
- psychological disorders
- pregnancy or nursing
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Montelukast Montelukast - Vitamin B6 Montelukast -
- Primary Outcome Measures
Name Time Method Montelukast will up-regulate airway regulatory T cell in the patients with asthma 4wks of treatment period
- Secondary Outcome Measures
Name Time Method Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma 4wks of treatment periods
Trial Locations
- Locations (1)
Kurume University School of Medicine
🇯🇵Kurume, Japan