NCT02368080

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

January 14, 2015

Last Update Submit

July 29, 2015

Conditions

Cystic FibrosisHealthy

Keywords

Lung Clearance IndexCystic FibrosisMultiple Breath Nitrogen Washout

Outcome Measures

Primary Outcomes (1)

  • Lung Clearance Index (LCI)

    1 hour

Secondary Outcomes (2)

  • Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)

    1 hour

  • Functional residual capacity (FRC) ( the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)

    1 hour

Other Outcomes (1)

  • Subject's preference

    1 hour

Study Arms (2)

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 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"

Interventions

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.

Cystic fibrosis adults (CF)Healthy adults (HC)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CF : primary care clinic HC : community sample

You may qualify if:

  • Cystic fibrosis diagnosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Patrick Lebecque, MD, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY DIRECTOR

  • William Poncin, PhD student

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

  • Anne-Sophie Aubriot, PhD student

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 14, 2015

First Posted

February 20, 2015

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

BE(1)