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

Mild Persistent Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581710
• Other study ID #: CHA-121
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: March 14, 2018
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Mild Persistent Asthma

Intervention

Drug:
• Montelukast to placebo
Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
• Placebo to montelukast
Subjects will receive matching placebo. Each treatment period consists of 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CHA University	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator	Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator	up to 2 weeks
Primary	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
Primary	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
Primary	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
Primary	Baseline Lung Function in MMEF	Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator	up to 2 weeks
Secondary	Relative Change (%) of FEV1 After the Bronchodilator	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