N/A N=32 Randomized Quadruple-blind Prevention

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

Mild Persistent Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01581710 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5) — 0.73; 0.74; 0.73 kPa/L/s

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Montelukast to placebo (Drug); Placebo to montelukast (Drug)
Age: Pediatric · 3+ yrs
Sex: All
Sponsor: CHA University
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)	0.73; 0.74; 0.73	—
PRIMARY Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)	-0.34; -0.36; -0.34	—
PRIMARY Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator	0.57; 0.55; 0.55	—
PRIMARY Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)	-0.15; -0.20; -0.19	—
PRIMARY Baseline Lung Function of FEV1 Before the Bronchodilator	1.28; 1.25; 1.28	—
PRIMARY Baseline Lung Function of FEV1/FVC Before the Bronchodilator	83.55; 83.04; 85.93	—
PRIMARY Baseline Lung Function in MMEF	1.40; 1.38; 1.46	—
SECONDARY Relative Change (%) of FEV1 After the Bronchodilator	9.68; 5.65	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01581710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.