Effects of Montelukast on Airway Regulatory T Cells in Asthma

Kurume University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Asthma

Treatments: Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT01951898

KU-012012

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Montelukast

Active Comparator group

Treatment:

Drug: Montelukast

Vitamin B6

Sham Comparator group

Treatment:

Drug: Montelukast