NCT02532894

Brief Summary

We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors. As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable healthy

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

October 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

August 24, 2015

Last Update Submit

October 8, 2021

Conditions

Healthy

Keywords

endothelial dysfunctionmicrovesiclesendothelial progenitor cellselectronic cigarettes

Outcome Measures

Primary Outcomes (2)

  • Change in number of endothelial progenitor cells

    24 hours

  • Change in number of micro vesicles

    24 hours

Secondary Outcomes (1)

  • Change in exhaled nitric oxide

    24 hours

Study Arms (2)

Esmoke

EXPERIMENTAL

Inhaling e-cigarette vapor

Device: Electronic cigarette

Control

NO INTERVENTION

Interventions

Electronic cigaretteDEVICE

Inhaling e-cigarette vapor

Esmoke

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects
  • sporadic cigarette smoking (\<9 cigarettes per month)

You may not qualify if:

  • Any form of cardiovascular disease
  • Any form of pulmonary disease like asthma or COPD
  • Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
  • Active allergy within 4 weeks of the study
  • Symptoms of infection or inflammation within 4 weeks of the study
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutionen för kliniska vetenskaper, Danderyds sjukhus

Danderyd, Stockholm County, 18288, Sweden

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Officials

  • Magnus Lundbäck, MD, PhD

    Institutionen för kliniska vetenskaper, Danderyds sjukhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD,

Study Record Dates

First Submitted

August 24, 2015

First Posted

August 26, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2014

Study Completion

March 1, 2016

Last Updated

October 11, 2021

Record last verified: 2021-10

Locations

SE(1)