NCT02950116

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 9, 2017

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2017

Completed
Last Updated

June 20, 2017

Status Verified

May 1, 2017

Enrollment Period

22 days

First QC Date

October 11, 2016

Last Update Submit

June 19, 2017

Conditions

AsthmaBronchiectasisCystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • S_cond

    Day 1

  • S_acin

    Day 1

  • Duration of the N2-MBW-test

    Day 1

  • Number of washout breaths

    Day 1

  • FRC

    Day 1

Study Arms (3)

Asthma

ACTIVE COMPARATOR

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

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

Non-CF bronchiectasis

ACTIVE COMPARATOR

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)

Cystic fibrosis

ACTIVE COMPARATOR

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)

Interventions

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

AsthmaCystic fibrosisNon-CF bronchiectasis

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

AsthmaBronchiectasisCystic Fibrosis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Hanneke Eyns, MSc, PT

    UZ Brussel Laarbeeklaan 101 1090 Brussels Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 31, 2016

Study Start

March 9, 2017

Primary Completion

March 31, 2017

Study Completion

April 7, 2017

Last Updated

June 20, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)