Clinical trial NCT01581710: Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Persistent Asthma
Keywords: Leukotriene Antagonists
Bronchodilator response
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-04-20
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
timeFrame: up to 2 weeks
measure: Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)
timeFrame: up to 2 weeks
measure: Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator
timeFrame: up to 2 weeks
measure: Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)
timeFrame: up to 2 weeks
measure: Baseline Lung Function of FEV1 Before the Bronchodilator
timeFrame: up to 2 weeks
measure: Baseline Lung Function of FEV1/FVC Before the Bronchodilator
timeFrame: up to 2 weeks
measure: Baseline Lung Function in MMEF
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Relative Change (%) of FEV1 After the Bronchodilator
timeFrame: up to 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: specify Unaffiliated
name: Man Yong Han
role: PRINCIPAL_INVESTIGATOR
References: