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Status unknownNCT01951898Updated Sep 27, 2013

Effects of Montelukast on Airway Regulatory T Cells in Asthma

A Phase 2/3 interventional study of Montelukast in Asthma, sponsored by Kurume University. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-09-27.

Sponsored by Kurume University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • asthma
  • regulatory T cells
  • leukotriene antagonist
03

In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's planned enrollment of 15 is below the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Kurume University is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • asthma
  • mild status
  • stable status
  • nonsmoker
  • Positive of airway hyperresponsiveness (Methacholine-PC20\<16mg/mL)

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (estimated)

Study arms

  • Active comparator
    Montelukast

    Drug: Montelukast

  • Sham comparator
    Vitamin B6

    Drug: Montelukast

Interventions

  • DrugMontelukast

    10mg/day, once a daily after dinner, for 28dyas

06

What researchers measure

Primary outcomes

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

    Time frame: 4wks of treatment period

Secondary outcomes

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

    Time frame: 4wks of treatment periods

07

Study locations

1 of 1 sites recruiting
  • Kurume University School of Medicine
    Kurume, Japan
    • Tomotaka Kawayama, MD · Contact
    • Tomotaka Kawayama, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01951898
Lead sponsor
Kurume University
Responsible party
Tomotaka Kawayama (MD, Kurume University) — Principal investigator
First posted
Sep 27, 2013
Start date
Jun 2012
Primary completion
Dec 2013 (estimated)
Completion
May 2015 (estimated)
Last update
Sep 27, 2013

Study contacts

Tomotaka Kawayama, MD
Contact
kawayama_tomotaka@med.kurume-u.ac.jp
+81-942-31-7560
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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