NCT02899234

Brief Summary

According to the World Health Organization cigarette smoking is today one of the leading single causes of preventable death and morbidity. The electronic cigarette (e-cigarette) has been marketed as a safer alternative to conventional cigarettes, and its global sales continue to grow exponentially each year. Despite growing e-cigarette use, scientific data on health effects are insufficient in some respects and completely lacking in others. Therefore the current study is designed to investigate the effects of active e-cigarette inhalation on the cardiovascular and respiratory systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

September 8, 2016

Last Update Submit

October 3, 2018

Conditions

Healthy

Keywords

NicotineElectronic Cigarette

Outcome Measures

Primary Outcomes (1)

  • Arterial Stiffness

    Pulse wave analysis (PWA), pulse wave velocity (PWV). Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%).

    1 day

Secondary Outcomes (4)

  • Lung function

    1 day

  • Cardiovascular biomarkers

    1 day

  • Impulse oscillometry

    1 day

  • Microcirculation assessment

    1 day

Study Arms (2)

Nicotine-free e-cigarette

ACTIVE COMPARATOR

Subjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests.

Other: E-cigarette

Nicotine e-cigarette

ACTIVE COMPARATOR

Subjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests.

Other: E-cigarette

Interventions

E-cigaretteOTHER

A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.

Nicotine e-cigaretteNicotine-free e-cigarette

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Intermittent/sporadic cigarette smoking
  • Normal clinical examination
  • Normal EKG
  • Normal blood tests
  • Normal lung function

You may not qualify if:

  • Cardiovascular disease
  • Respiratory disease
  • Systemic or chronic disorders or disease
  • Symptoms of infection or inflammation within 2 weeks of the study
  • BMI≥30
  • Pregnancy
  • Current habitual cigarette smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Medicine, Lung and Allergy section, University Hospital

Umeå, Sweden

Location

MeSH Terms

Conditions

Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jenny A Bosson, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 14, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations

SE(1)