NCT03410511

Brief Summary

Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 11, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

January 11, 2018

Last Update Submit

November 2, 2020

Conditions

Lung Injury

Outcome Measures

Primary Outcomes (1)

  • Change in cardiorespiratory function

    Continuous monitoring of cardiorespiratory function

    4 hours

Secondary Outcomes (1)

  • Change in serum and urine proteomics profiles

    1 hour

Other Outcomes (1)

  • Change in serum and exhaled breath condensate metabolomics profiles

    1 hour

Study Arms (3)

Nicotine free intake

EXPERIMENTAL

The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.

Other: Nicotine free intake

Nicotine intake

EXPERIMENTAL

The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol/nicotine (mix 50:50) intake.

Other: Nicotine intake

Cessation intake

EXPERIMENTAL

The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.

Other: Cessation intake

Interventions

Nicotine free intakeOTHER

The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.

Nicotine free intake
Nicotine intakeOTHER

The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.

Nicotine intake
Cessation intakeOTHER

The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.

Cessation intake

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject must be regular propylene glycol/glycerol/nicotine intake users since at least 1 year
  • Subject must be former smokers

You may not qualify if:

  • Chronic or acute illness
  • Substance abuse
  • Chronic medication intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, Anderlecht, 1070, Belgium

Location

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Officials

  • Philippe van de Borne, MD, PhD

    Université Libre de Bruxelles

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 25, 2018

Study Start

January 15, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication. No end date.
Access Criteria
Any purpose Proposals should be directed to martin.chaumont@ulb.ac.be

Locations

BE(1)