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

CHA University0 sites32 target enrollmentMay 2012

ConditionsMild Persistent Asthma

InterventionsMontelukast to placebo Placebo to montelukast

DrugsMontelukast to placebo Placebo to montelukast

Overview

Phase: Not Applicable
Intervention: Montelukast to placebo
Conditions: Mild Persistent Asthma
Sponsor: CHA University
Enrollment: 32
Primary Endpoint: Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

December 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

CHA University

Responsible Party

Principal Investigator

Man Yong Han

Professor

CHA University

Eligibility Criteria

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.