Asthma
Conditions
Keywords
asthma, regulatory T cells, leukotriene antagonist
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.
Interventions
DRUGMontelukast
10mg/day, once a daily after dinner, for 28dyas
Sponsors
Kurume University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* asthma * mild status * stable status * nonsmoker * Positive of airway hyperresponsiveness (Methacholine-PC20\<16mg/mL)
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montelukast will up-regulate airway regulatory T cell in the patients with asthma | 4wks of treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma | 4wks of treatment periods |
Countries
Japan
Contacts
Primary ContactTomotaka Kawayama, MD
Outcome results
None listed