Effects of Montelukast on Airway Regulatory T Cells in Asthma

Asthma Clinical Trial

Official title:

Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01951898
• Other study ID #: KU-012012
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 2, 2012
• Last updated: September 24, 2013
• Start date: June 2012
• Est. completion date: May 2015

Study information

• Verified date: September 2013
• Source: Kurume University
• Contact: Tomotaka Kawayama, MD
• Phone: +81-942-31-7560
• Email: kawayama_tomotaka[@]med.kurume-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast
10mg/day, once a daily after dinner, for 28dyas

Locations

Country	Name	City	State
Japan	Kurume University School of Medicine	Kurume

Sponsors (1)

Lead Sponsor	Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montelukast will up-regulate airway regulatory T cell in the patients with asthma		4wks of treatment period	Yes
Secondary	Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma		4wks of treatment periods	Yes