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

Not Applicable

Completed

• Conditions: Mild Persistent Asthma
• Interventions: Drug: Montelukast to placebo; Drug: Placebo to montelukast

• Registration Number: NCT01581710
• Lead Sponsor: CHA University

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.

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 Timeline

• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-05
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Results First Submitted: 2017-07-31
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-14
• Last Update Submitted: 2018-03-14
• Results First Posted: 2018-04-12
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
montelukast to placebo	Montelukast to placebo	14 days
Placebo to montelukast	Placebo to montelukast	14 days

Primary Outcome Measures

Name	Time	Method
Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)	up to 2 weeks	Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator
Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)	up to 2 weeks	Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator
Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator	up to 2 weeks	Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator
Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)	up to 2 weeks	Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator
Baseline Lung Function of FEV1 Before the Bronchodilator	up to 2 weeks	baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator
Baseline Lung Function of FEV1/FVC Before the Bronchodilator	up to 2 weeks	baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator
Baseline Lung Function in MMEF	up to 2 weeks	Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator

Secondary Outcome Measures

Name	Time	Method
Relative Change (%) of FEV1 After the Bronchodilator	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