Effects of Montelukast on Airway Regulatory T Cells in As... | NCT01951898

Studies
Effects of Montelukast on Airway Regulatory T Cells in Asthma

NCT01951898

Sponsor

Kurume University

Status

Unknown status

Last Update Posted

Sep 27, 2013Estimated

Enrollment

15Estimated

Phase

Phase 2Phase 3

Conditions

Asthma

Interventions

Montelukast

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

May 2015Estimated

First Submitted Date

May 2, 2012

First Submission Date that Met QC Criteria

Sep 24, 2013

First Posted Date

Sep 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2013

Last Update Posted Date

Sep 27, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Montelukast	Active Comparator		Drug: Montelukast
Vitamin B6	Sham Comparator		Drug: Montelukast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Montelukast	Drug	10mg/day, once a daily after dinner, for 28dyas	Montelukast Vitamin B6

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montelukast will up-regulate airway regulatory T cell in the patients with asthma		4wks of treatment period

Secondary Outcomes

Measure	Description	Time Frame
Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma		4wks of treatment periods

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tomotaka Kawayama, MD	Contact	+81-942-31-7560		kawayama_tomotaka@med.kurume-u.ac.jp

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kurume University School of Medicine	Recruiting	Kurume			Japan

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided