Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368080
• Other study ID #: StLuc MBWN2 01
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: July 29, 2015
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2015
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Cystic fibrosis diagnosis

Exclusion Criteria:

• Respiratory infection within 3 weeks

• Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Healthy

Intervention

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.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject's preference	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).	1 hour	No
Primary	Lung Clearance Index (LCI)		1 hour	No
Secondary	Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)	Difference in discriminative ability between devices will be assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device	1 hour	No
Secondary	Functional residual capacity (FRC) ( the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)	FRC will be compared with a third device in a subset of 11 healthy adults : the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)	1 hour	No