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

NCT ID: NCT01581710

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Mild Persistent Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

montelukast to placebo

14 days

Group Type: ACTIVE_COMPARATOR

Montelukast to placebo

Intervention Type: DRUG

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

Washout

14 days

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo to montelukast

14 days

Group Type: ACTIVE_COMPARATOR

Placebo to montelukast

Intervention Type: DRUG

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

Interventions

Montelukast to placebo

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

Intervention Type: DRUG

Placebo to montelukast

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

Intervention Type: DRUG

Other Intervention Names

SINGULAIR 4mg or 5mg; SINGULAIR 4mg or 5mg matching placebo

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

CHA University

OTHER

Sponsor Role: lead

Responsible Party

Man Yong Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Man Yong Han

Role: PRINCIPAL_INVESTIGATOR

specify Unaffiliated

Other Identifiers

CHA-121

Identifier Type: -

Identifier Source: org_study_id