An interventional study of Nicotine free intake and Nicotine intake in Lung Injury, sponsored by Université Libre de Bruxelles. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Basic science
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Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.
Background. Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown. Weaning of propylene glycol/glycerol could allows a quick clearance of propylene glycol/glycerol from the body, with subsequent recovery of cardiorespiratory function.
Specific aim of the research. This research proposal tests the following hypothesis regarding the reversibility of propylene glycol/glycerol and nicotine intake:
114 studies on the registry are indexed under Lung Injury; 33 are open to participants now.
This study's enrollment of 30 is below the median of 62 across 75 interventional studies indexed under Lung Injury.
Browse Lung Injury studies →Université Libre de Bruxelles is the lead sponsor of 45 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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.
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.
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.
Change in cardiorespiratory function
Continuous monitoring of cardiorespiratory function
Time frame: 4 hours
Change in serum and urine proteomics profiles
Serum and urine proteomics
Time frame: 1 hour
Change in serum and exhaled breath condensate metabolomics profiles
Serum and exhaled breath condensate metabolomics
Time frame: 1 hour
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Immediately following publication. No end date.
Access criteria: Any purpose Proposals should be directed to martin.chaumont@ulb.ac.be
Ran from Jan 2018 to primary completion in Jun 2019, 17 months.
Of 28 interventional studies with no phase under Lung Injury, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 69. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Université Libre de Bruxelles