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Completed

NCT Number: NCT02378454

Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Healthy Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cystic fibrosis diagnosis

Exclusion criteria

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

Treatment and study plan

Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"

Device

Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.

Primary outcomes

  1. Lung Clearance Index (LCI)

    Time frame: 1 hour

Secondary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children: A Comparison of Two Commercially Available Devices

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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