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

Asthma Clinical Trial

Official title:

Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02950116
• Other study ID #: LCI-OLD-ped
• Status: Terminated
• Phase: N/A
• First received: October 11, 2016
• Last updated: June 19, 2017
• Start date: March 9, 2017
• Est. completion date: April 7, 2017

Study information

• Verified date: May 2017
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 7, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchiectasis
• Cystic Fibrosis
• Lung Diseases
• Lung Diseases, Obstructive

Intervention

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.)

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	S_cond	S_cond will be calculated from the N2-MBW-test with the lowest LCI	Day 1
Secondary	S_acin	S_acin will be calculated from the N2-MBW-test with the lowest LCI	Day 1
Secondary	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
Secondary	Number of washout breaths	Will be determined at the end of the N2-MBW-test	Day 1
Secondary	FRC	FRC will be calculated from the N2-MBW-test	Day 1