Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease

Not Applicable

Terminated

• Conditions: Asthma; Bronchiectasis; Cystic Fibrosis
• Interventions: Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test)

• Registration Number: NCT02950116
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

Chronic respiratory diseases (CRDs) affect the airways and other structures of the lungs and thereby lead to ventilation inhomogeneity. The most common CRDs in children are asthma, bronchiectasis and cystic fibrosis (CF). All three are obstructive diseases. However, while asthma is mostly characterized by obstruction due to bronchoconstriction of the airways, obstruction in bronchiectasis and CF originates primarily from mucus retention due to abnormal airway clearance mechanisms.

The Nitrogen Multiple Breath Washout test (N2-MBW-test) is a robust and sensitive detector of early pulmonary changes and ventilation inhomogeneity. The minimal cooperation which is required for this test makes it very convenient for use in any age category.

Research on LCI described it as a reliable indicator of obstructive lung disease in pediatric CF patients as from 6 years of age. Whether LCI is a reliable parameter for early lung disease in asthma children is less clearly demonstrated. No data were found on LCI calculated from the N2-MBW-test in children with bronchiectasis.

Detailed Description

Subjects of all the intervention groups will perform three consecutive nitrogen multiple breath washout tests (N2-MBW-tests) when attending the Universitair Ziekenhuis Brussel (UZB) for their scheduled pulmonology consultation. Only the best measurement (based on LCI result) will be taken into account when comparing the groups. Every subject will be positioned in the same seated position.

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Study Start: 2017-03-09
• Primary Completion: 2017-03-31
• Study Completion: 2017-04-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Patients with stable asthma
• Patients with non-CF bronchiectasis
• Patients with cystic fibrosis
• Aged 6-17 years
• FEV1 (%pred) >50%
• Written informed consent from the parents or legal guardian

Exclusion Criteria

• Unstable disease (e.g. pulmonary exacerbation, acute deterioration, acute asthma crisis)
• Patients mentally not capable to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystic fibrosis	Perform three multiple breath nitrogen washout tests (N2-MBW-test)	Patients with cystic fibrosis will perform three multiple breath nitrogen washout tests (N2-MBW-test)
Asthma	Perform three multiple breath nitrogen washout tests (N2-MBW-test)	Asthmatic patients will perform three multiple breath nitrogen washout tests (N2-MBW-test)
Non-CF bronchiectasis	Perform three multiple breath nitrogen washout tests (N2-MBW-test)	Patients with non-CF bronchiectasis will perform three multiple breath nitrogen washout tests (N2-MBW-test)

Primary Outcome Measures

Name	Time	Method
LCI	Day 1	LCI will be calculated from the 3 N2-MBW-tests. The test with the lowest LCI will be used for analysis of the other outcome measurements.

Secondary Outcome Measures

Name	Time	Method
S_acin	Day 1	S_acin will be calculated from the N2-MBW-test with the lowest LCI
Number of washout breaths	Day 1	Will be determined at the end of the N2-MBW-test
FRC	Day 1	FRC will be calculated from the N2-MBW-test
Duration of the N2-MBW-test	Day 1	Duration of the N2-MBW-test with the lowest LCI will be taken into account for analysis
S_cond	Day 1	S_cond will be calculated from the N2-MBW-test with the lowest LCI

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium