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Effects of Montelukast on Airway Regulatory T Cells in Asthma

NCT ID: NCT01951898

Last Updated: 2013-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma regulatory T cells leukotriene antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Montelukast

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

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

Vitamin B6

Group Type SHAM_COMPARATOR

Montelukast

Intervention Type DRUG

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

Interventions

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Montelukast

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kurume University

OTHER

Sponsor Role lead

Responsible Party

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Tomotaka Kawayama

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kurume University School of Medicine

Kurume, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Tomotaka Kawayama, MD

Role: CONTACT

Phone: +81-942-31-7560

Email: [email protected]

Facility Contacts

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Tomotaka Kawayama, MD

Role: primary

Other Identifiers

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KU-012012

Identifier Type: -

Identifier Source: org_study_id