Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
18 October 2021 |
Main ID: |
NCT02532894 |
Date of registration:
|
24/08/2015 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers
ESMOKE |
Scientific title:
|
|
Date of first enrolment:
|
October 2014 |
Target sample size:
|
16 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02532894 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Sweden
| | | | | | | |
Contacts
|
Name:
|
Magnus Lundbäck, MD, PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Institutionen för kliniska vetenskaper, Danderyds sjukhus |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- healthy subjects
- sporadic cigarette smoking (<9 cigarettes per month)
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Healthy
|
Intervention(s)
|
Device: Electronic cigarette
|
Primary Outcome(s)
|
Change in number of micro vesicles
[Time Frame: 24 hours]
|
Change in number of endothelial progenitor cells
[Time Frame: 24 hours]
|
Secondary Outcome(s)
|
Change in exhaled nitric oxide
[Time Frame: 24 hours]
|
Secondary ID(s)
|
214/552-31/4
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|