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Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults

NCT ID: NCT02368080

Last Updated: 2015-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cystic Fibrosis Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cystic fibrosis adults (CF)

No treatment, comparison of LCI values obtained with two devices

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

Intervention Type DEVICE

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.

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cystic fibrosis diagnosis

Exclusion Criteria

* Respiratory infection within 3 weeks
* Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Poncin

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Lebecque, MD, PhD

Role: STUDY_DIRECTOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

William Poncin, PhD student

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Anne-Sophie Aubriot, PhD student

Role: STUDY_CHAIR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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StLuc MBWN2 01

Identifier Type: -

Identifier Source: org_study_id

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