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Effects of Montelukast on Airway Regulatory T Cells in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01951898
Recruitment Status : Unknown
Verified September 2013 by Tomotaka Kawayama, Kurume University.
Recruitment status was:  Recruiting
First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):
Tomotaka Kawayama, Kurume University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Montelukast Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics
Study Start Date : June 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

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

Primary Outcome Measures :
  1. Montelukast will up-regulate airway regulatory T cell in the patients with asthma [ Time Frame: 4wks of treatment period ]

Secondary Outcome Measures :
  1. Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma [ Time Frame: 4wks of treatment periods ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01951898

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Contact: Tomotaka Kawayama, MD +81-942-31-7560

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Kurume University School of Medicine Recruiting
Kurume, Japan
Contact: Tomotaka Kawayama, MD         
Principal Investigator: Tomotaka Kawayama, MD         
Sponsors and Collaborators
Kurume University

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Responsible Party: Tomotaka Kawayama, MD, Kurume University Identifier: NCT01951898    
Other Study ID Numbers: KU-012012
First Posted: September 27, 2013    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013
Keywords provided by Tomotaka Kawayama, Kurume University:
regulatory T cells
leukotriene antagonist
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action