Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.

March 14, 2018 updated by: Man Yong Han, CHA University

A Double-blind, Randomized, Cross-over Design Study to Compare the Lung Function Measure of Montelukast Versus Placebo in Children With Mild Persistent Asthma

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

Study Overview

Detailed Description

This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period.

After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test.

Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, 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, or admission or visit of the emergency department during the previous 4 weeks.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: montelukast to placebo
14 days
Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
Other Names:
  • SINGULAIR 4mg or 5mg
No Intervention: Washout
14 days
Active Comparator: Placebo to montelukast
14 days
Subjects will receive matching placebo. Each treatment period consists of 2 weeks
Other Names:
  • SINGULAIR 4mg or 5mg matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
Time Frame: up to 2 weeks
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)
Time Frame: up to 2 weeks
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
Time Frame: up to 2 weeks
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)
Time Frame: up to 2 weeks
Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator
up to 2 weeks
Baseline Lung Function of FEV1 Before the Bronchodilator
Time Frame: up to 2 weeks
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
Time Frame: up to 2 weeks
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
Time Frame: up to 2 weeks
Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative Change (%) of FEV1 After the Bronchodilator
Time Frame: up to 2 weeks
Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Man Yong Han, specify Unaffiliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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