Effects of Montelukast on Airway Regulatory T Cells in Asthma

• Status: Unknown status
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kurume University
• Treatments: Montelukast

Criteria

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