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

Primary Purpose

Asthma, Bronchiectasis, Cystic Fibrosis

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Perform three multiple breath nitrogen washout tests (N2-MBW-test)
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Asthma

Non-CF bronchiectasis

Cystic fibrosis

Arm Description

Asthmatic patients will 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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2016
Last Updated
June 19, 2017
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02950116
Brief Title
Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease
Official Title
Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Availabe time for inclusion ended (master thesis)
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchiectasis, Cystic Fibrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma
Arm Type
Active Comparator
Arm Description
Asthmatic patients will perform three multiple breath nitrogen washout tests (N2-MBW-test)
Arm Title
Non-CF bronchiectasis
Arm Type
Active Comparator
Arm Description
Patients with non-CF bronchiectasis will perform three multiple breath nitrogen washout tests (N2-MBW-test)
Arm Title
Cystic fibrosis
Arm Type
Active Comparator
Arm Description
Patients with cystic fibrosis will perform three multiple breath nitrogen washout tests (N2-MBW-test)
Intervention Type
Device
Intervention Name(s)
Perform three multiple breath nitrogen washout tests (N2-MBW-test)
Intervention Description
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.)
Primary Outcome Measure Information:
Title
LCI
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
S_cond
Description
S_cond will be calculated from the N2-MBW-test with the lowest LCI
Time Frame
Day 1
Title
S_acin
Description
S_acin will be calculated from the N2-MBW-test with the lowest LCI
Time Frame
Day 1
Title
Duration of the N2-MBW-test
Description
Duration of the N2-MBW-test with the lowest LCI will be taken into account for analysis
Time Frame
Day 1
Title
Number of washout breaths
Description
Will be determined at the end of the N2-MBW-test
Time Frame
Day 1
Title
FRC
Description
FRC will be calculated from the N2-MBW-test
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanneke Eyns, MSc, PT
Organizational Affiliation
UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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