Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378454
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:
This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.

Condition or disease Intervention/treatment
Cystic Fibrosis Healthy Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"

Detailed Description:
Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children: A Comparison of Two Commercially Available Devices
Study Start Date : August 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
Cystic fibrosis adults (CF)
No treatment, comparison of LCI values obtained with two devices
Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"
Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.

Healthy adults (HC)
No treatment, comparison of LCI values obtained with two devices Free of respiratory disease or others diseases likely to disturb respiratory system.
Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"
Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.




Primary Outcome Measures :
  1. Lung Clearance Index (LCI) [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device) [ Time Frame: 1 hour ]
    Difference in discriminative ability between devices will be assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device

  2. Spirometry [ Time Frame: 20 minutes ]
    Forced expired volume in one second (FEV1) and Forced expired flow at 25-75% of the forced vital capacity (FEF25-75) will be measured and correlated with LCI


Other Outcome Measures:
  1. Subject's preference [ Time Frame: 1 hour ]
    Just after the completion of the tests, subjects will be asked to answer which one of the device they most preferred (i.e.: device A or device B or no preference).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
CF : primary care clinic HC : community sample
Criteria

Inclusion Criteria:

  • Cystic fibrosis diagnosis

Exclusion Criteria:

  • Respiratory infection within 3 weeks
  • Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378454


Locations
Layout table for location information
Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Layout table for investigator information
Study Director: Patrick Lebecque, MD, PhD Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Principal Investigator: William Poncin, PhD student Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Chair: Anne-Sophie Aubriot, PhD student Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Layout table for additonal information
Responsible Party: Poncin, Physiotherapist, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02378454     History of Changes
Other Study ID Numbers: StLuc MBWN2 02
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Lung Clearance Index
Cystic Fibrosis
Multiple Breath Nitrogen Washout
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases