Effects of Montelukast on Airway Regulatory T Cells in Asthma

Phase 2

• Conditions: Asthma
• Interventions: Drug: Montelukast

• 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

Study Timeline

• Study First Submitted: 2012-05-02
• Study Start: 2012-06
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-24
• Last Update Submitted: 2013-09-24
• Study First Posted: 2013-09-27
• Last Update Posted: 2013-09-27
• Primary Completion: 2013-12
• Study Completion: 2015-05

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)

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

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