Effects of Montelukast on Airway Regulatory T Cells in Asthma

September 24, 2013 updated by: Tomotaka Kawayama, Kurume University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Kurume, Japan
        • Recruiting
        • Kurume University School of Medicine
        • Contact:
          • Tomotaka Kawayama, MD
        • Principal Investigator:
          • Tomotaka Kawayama, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Montelukast
Drug: Montelukast
10mg/day, once a daily after dinner, for 28dyas
SHAM_COMPARATOR: Vitamin B6
Drug: Montelukast
10mg/day, once a daily after dinner, for 28dyas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montelukast will up-regulate airway regulatory T cell in the patients with asthma
Time Frame: 4wks of treatment period
4wks of treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma
Time Frame: 4wks of treatment periods
4wks of treatment periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kurume University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

May 1, 2015

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

September 24, 2013

First Posted (ESTIMATE)

September 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU-012012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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