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Effects of Montelukast on Airway Regulatory T Cells in Asthma

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Montelukast
Sponsored by
Kurume University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, regulatory T cells, leukotriene antagonist

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Kurume University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Montelukast

Vitamin B6

Arm Description

Outcomes

Primary Outcome Measures

Montelukast will up-regulate airway regulatory T cell in the patients with asthma

Secondary Outcome Measures

Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma

Full Information

First Posted
May 2, 2012
Last Updated
September 24, 2013
Sponsor
Kurume University
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1. Study Identification

Unique Protocol Identification Number
NCT01951898
Brief Title
Effects of Montelukast on Airway Regulatory T Cells in Asthma
Official Title
Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kurume University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, regulatory T cells, leukotriene antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Montelukast
Arm Type
Active Comparator
Arm Title
Vitamin B6
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
10mg/day, once a daily after dinner, for 28dyas
Primary Outcome Measure Information:
Title
Montelukast will up-regulate airway regulatory T cell in the patients with asthma
Time Frame
4wks of treatment period
Secondary Outcome Measure Information:
Title
Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma
Time Frame
4wks of treatment periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomotaka Kawayama, MD
Phone
+81-942-31-7560
Email
kawayama_tomotaka@med.kurume-u.ac.jp
Facility Information:
Facility Name
Kurume University School of Medicine
City
Kurume
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomotaka Kawayama, MD
First Name & Middle Initial & Last Name & Degree
Tomotaka Kawayama, MD

12. IPD Sharing Statement

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Effects of Montelukast on Airway Regulatory T Cells in Asthma

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