NCT03447418

Brief Summary

This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
191

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 6, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

February 19, 2018

Last Update Submit

January 26, 2021

Conditions

Healthy

Keywords

Lung Clearance IndexBreath Nitrogen WashoutHealthy subjects

Outcome Measures

Primary Outcomes (1)

  • Lung Clearance Index 2.5% (LCI 2.5%) Value

    Multiple breath washout is a pulmonary function test that does not require patients' cooperation. It studies the number of lung volumes (turn-over) to clear a gaz such as nitrogen form the lungs. LCI 2,5 is most frequently reported outcome measure. It corresponds to the sum of the total expired lung volumes needed to decrease the initial gaz concretion to its 1/40th, divided by functional residual capacity. LCI can be measured in infant, preschoolers and thereafter. In order to obtain reproducible tests, three acceptable maneuvers are needed.

    hour 1

Secondary Outcomes (5)

  • Lung Clearance Index 5% (LCI 5%) Value

    hour 1

  • Moment ratio M1/M0 Value

    up to 1 hour

  • Moment ratio M0/M2 Value

    up to 1 hour

  • Sacin value

    hour 1

  • Scond value

    hour 1

Study Arms (1)

no treatment, open label

OTHER
Procedure: Multiple breath nitrogen washout

Interventions

Multiple breath nitrogen washoutPROCEDURE

Lung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device.

no treatment, open label

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent by participant, parent, or legal guardian
  • Healthy subjects with a social insurance

You may not qualify if:

  • History of a lung chronic disease
  • Premature birth (\<37th weeks of amenorrhea)
  • Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, France

RECRUITING

Central Study Contacts

Philippe REIX, Pr

CONTACT

427 85 54 70philippe.reix@chu-lyon.fr

Marie PERCEVAL

CONTACT

427 85 59 87marie.perceval@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 27, 2018

Study Start

July 6, 2018

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

FR(1)