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

Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease

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.

Study Overview

• Status: Terminated
• Conditions: Bronchiectasis; Asthma; Cystic Fibrosis
• Intervention / Treatment: Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test)

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Asthma; Asthmatic patients will perform three multiple breath nitrogen washout tests (N2-MBW-test)	Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test); Patient is sitting in upright position, nose clip in place and breathing through a mouth piece with filter (neither sitting forward with back bent, nor supporting arms such that shoulders are raised); Patient's breathing pattern is stable for a minimum of 5 breaths; Start of washout by inhaling 100% oxygen (initiated by lab technician); Continuous stable breathing pattern until end of washout test; End target = 1/40th of start N2 concentration; To ensure end of washout is achieved, patients should breathe 5 more breaths below the target concentration before the trial is terminated; Three N2-MBW-tests are performed consecutively. Time between each test is [duration of the previous test*1.5] (e.g. test duration = 6 min., time to next test = 6*1.5 = 9 min.)
Active Comparator: Non-CF bronchiectasis; Patients with non-CF bronchiectasis will perform three multiple breath nitrogen washout tests (N2-MBW-test)	Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test); Patient is sitting in upright position, nose clip in place and breathing through a mouth piece with filter (neither sitting forward with back bent, nor supporting arms such that shoulders are raised); Patient's breathing pattern is stable for a minimum of 5 breaths; Start of washout by inhaling 100% oxygen (initiated by lab technician); Continuous stable breathing pattern until end of washout test; End target = 1/40th of start N2 concentration; To ensure end of washout is achieved, patients should breathe 5 more breaths below the target concentration before the trial is terminated; Three N2-MBW-tests are performed consecutively. Time between each test is [duration of the previous test*1.5] (e.g. test duration = 6 min., time to next test = 6*1.5 = 9 min.)
Active Comparator: Cystic fibrosis; Patients with cystic fibrosis will perform three multiple breath nitrogen washout tests (N2-MBW-test)	Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test); Patient is sitting in upright position, nose clip in place and breathing through a mouth piece with filter (neither sitting forward with back bent, nor supporting arms such that shoulders are raised); Patient's breathing pattern is stable for a minimum of 5 breaths; Start of washout by inhaling 100% oxygen (initiated by lab technician); Continuous stable breathing pattern until end of washout test; End target = 1/40th of start N2 concentration; To ensure end of washout is achieved, patients should breathe 5 more breaths below the target concentration before the trial is terminated; Three N2-MBW-tests are performed consecutively. Time between each test is [duration of the previous test*1.5] (e.g. test duration = 6 min., time to next test = 6*1.5 = 9 min.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LCI	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.	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Hanneke Eyns, MSc, PT, UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): April 7, 2017

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Bronchiectasis; Lung Diseases; Lung Diseases, Obstructive; Cystic Fibrosis
• Other Study ID Numbers: LCI-OLD-ped

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No