NCT01951898

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 27, 2013

Status Verified

September 1, 2013

Enrollment Period

1.5 years

First QC Date

May 2, 2012

Last Update Submit

September 24, 2013

Conditions

Asthma

Keywords

asthmaregulatory T cellsleukotriene antagonist

Outcome Measures

Primary Outcomes (1)

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

    4wks of treatment period

Secondary Outcomes (1)

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

    4wks of treatment periods

Study Arms (2)

Montelukast

ACTIVE COMPARATOR
Drug: Montelukast

Vitamin B6

SHAM COMPARATOR
Drug: Montelukast

Interventions

MontelukastDRUG

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

MontelukastVitamin B6

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kurume University School of Medicine

Kurume, Japan

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Tomotaka Kawayama, MD

CONTACT

+81-942-31-7560kawayama_tomotaka@med.kurume-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 2, 2012

First Posted

September 27, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

May 1, 2015

Last Updated

September 27, 2013

Record last verified: 2013-09

Locations

JP(1)