NCT01581710

Brief Summary

This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Status
completed

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

April 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 12, 2018

Completed
Last Updated

April 12, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

April 13, 2012

Results QC Date

July 31, 2017

Last Update Submit

March 14, 2018

Conditions

Mild Persistent Asthma

Keywords

Leukotriene AntagonistsBronchodilator response

Outcome Measures

Primary Outcomes (7)

  • Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)

    Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator

    up to 2 weeks

  • Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)

    Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator

    up to 2 weeks

  • Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator

    Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator

    up to 2 weeks

  • Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)

    Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator

    up to 2 weeks

  • Baseline Lung Function of FEV1 Before the Bronchodilator

    baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator

    up to 2 weeks

  • Baseline Lung Function of FEV1/FVC Before the Bronchodilator

    baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator

    up to 2 weeks

  • Baseline Lung Function in MMEF

    Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator

    up to 2 weeks

Secondary Outcomes (1)

  • Relative Change (%) of FEV1 After the Bronchodilator

    up to 2 weeks

Study Arms (3)

montelukast to placebo

ACTIVE COMPARATOR

14 days

Drug: Montelukast to placebo

Washout

NO INTERVENTION

14 days

Placebo to montelukast

ACTIVE COMPARATOR

14 days

Drug: Placebo to montelukast

Interventions

Montelukast to placeboDRUG

Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks

Also known as: SINGULAIR 4mg or 5mg
montelukast to placebo
Placebo to montelukastDRUG

Subjects will receive matching placebo. Each treatment period consists of 2 weeks

Also known as: SINGULAIR 4mg or 5mg matching placebo
Placebo to montelukast

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children diagnosed with mild persistent asthma patients based on the GINA guidelines
  • children old enough to cooperate in performing pulmonary function testing
  • legal guardians who sufficiently listen to the purpose and voluntarily agree with the participation to sign a written consent approved by IRB
  • children with no respiratory symptoms 4 weeks prior to the beginning of the study
  • children without chronic respiratory symptoms.

You may not qualify if:

  • presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy.
  • use of systemic corticosteroids in past 4 weeks.
  • admission or visit of the emergency department in past 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

montelukast

Results Point of Contact

Title
Dr. HAN, MAN YONG
Organization
CHA UNIVERSITY
drmesh@gmail.com
82-31-780-6262

Study Officials

  • Man Yong Han

    specify Unaffiliated

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 20, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

April 12, 2018

Results First Posted

April 12, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share