Biomarkers in Dyspnea | NCT03056547

Studies
Biomarkers in Dyspnea

NCT03056547

Sponsor

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Status

Completed

Last Update Posted

Sep 13, 2019Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Induced dyspnea

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 23, 2017Actual

Primary Completion Date

Jan 8, 2019Actual

Completion Date

Jan 8, 2019Actual

First Submitted Date

Feb 15, 2017

First Submission Date that Met QC Criteria

Feb 16, 2017

First Posted Date

Feb 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2019

Last Update Posted Date

Sep 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To explore biological mechanisms in human model of induced dyspnea, in order to remove the source of dyspnoea, to modify cerebral impact and to allow the development of targeted therapies.

Detailed Description

The aim of the study will be to identify a specific biology and immunology associated with dyspnoea. It will open therapeutic possibilities through a better understanding of the mechanisms of dyspnea.

Healthy volunteers will underwent two types of dyspnea. The subjects will be first familiar with both types of dyspnea and dyspnea measurement scales. Different components of dyspnea will be measured.

Blood tests will be performed at different times (before dyspnea, during dyspnea, 60 and 90 min after dyspnea)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Induced dyspnea	Experimental		Other: Induced dyspnea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Induced dyspnea	Other	Biological samples will be assessed during and after breathing discomfort induced by laboratory models of dyspnea ("work/effort", "air hunger").	Induced dyspnea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biomakers in dyspnea	Biomarkers in human model of induced dyspnea	60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Correlation with dyspnea intensity	Correlation between intensity of dyspnea and biomarkers	60 minutes
Correlation with dyspnea type	Correlation between type of dyspnea and biomarkers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

pregnancy
ongoing pain
respiratory disease
high levels of depression, panic disorder, or other significant mental health problems
not fluent in french

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Investigation Clinique Paris Est - Groupe Hospitalier Pitié-Salpêtrière		Paris		75013	France