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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-09

Study Completion Date

2017-04-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma Bronchiectasis Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Asthma

Asthmatic patients will perform three multiple breath nitrogen washout tests (N2-MBW-test)

Group Type ACTIVE_COMPARATOR

Perform three multiple breath nitrogen washout tests (N2-MBW-test)

Intervention Type DEVICE

* 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.)

Non-CF bronchiectasis

Patients with non-CF bronchiectasis will perform three multiple breath nitrogen washout tests (N2-MBW-test)

Group Type ACTIVE_COMPARATOR

Perform three multiple breath nitrogen washout tests (N2-MBW-test)

Intervention Type DEVICE

* 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.)

Cystic fibrosis

Patients with cystic fibrosis will perform three multiple breath nitrogen washout tests (N2-MBW-test)

Group Type ACTIVE_COMPARATOR

Perform three multiple breath nitrogen washout tests (N2-MBW-test)

Intervention Type DEVICE

* 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.)

Interventions

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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.)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No