Effects of Montelukast on Airway Regulatory T Cells in Asthma

Phase 3UnknownNCT01951898

Kurume University15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

MontelukastDRUG

10mg/day, once a daily after dinner, for 28dyas

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Kurume University School of Medicine

Kurume, Japan

RECRUITING

Outcomes

Primary Outcomes

Montelukast will up-regulate airway regulatory T cell in the patients with asthma

Time frame: 4wks of treatment period

Secondary Outcomes

Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma

Time frame: 4wks of treatment periods

Central Contacts

Tomotaka Kawayama, MD

CONTACT

+81-942-31-7560 kawayama_tomotaka@med.kurume-u.ac.jp

Data from ClinicalTrials.gov

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