NCT02739438

Brief Summary

To carry out a prospective cohort study of healthy volunteers, assessing differences between baseline pulmonary inflammation, response to LPS inhalation and endothelial function, as measured by flow mediated dilation between, electronic cigarette uses, cigarette smokers and non smokers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

April 11, 2016

Last Update Submit

July 2, 2019

Conditions

Acute Lung Injury

Keywords

Pulmonary inflammationEndothelial dysfunctionElectronic Cigarettes

Outcome Measures

Primary Outcomes (1)

  • bronchoalveolar lavage neutrophil count in response to LPS stimulation

    BAL 6 hours after LPS inhalation

Secondary Outcomes (4)

  • Alveolar inflammatory response

    24 hours after LPS inhalation

  • Plasma inflammatory response

    24 hours after LPS inhalation

  • Indices of alveolar epithelial and endothelial and injury

    24 hours after LPS inhalation

  • 4. FMD of brachial artery as a marker of the effects of e-cigarettes on endothelial function

    5 mins within use of an electronic cigarette

Study Arms (3)

E Cigarette users

Subjects who use electronic cigarettes daily and have not used conventional cigarettes in the previous 3 months. Total pack years of smoking should be less than 20 for their smoking history, with normal lung function (FEV1 and FEV1/FVC) and no clinical symptoms of airway obstruction/inflammation (cough, dyspnea, sputum and wheeze).

Other: Electronic cigarette use

Cigarette smokers

Subjects who smoke at least ¼ pack cigarettes per day for the past 1 year, with no history of electronic cigarette use in the last 30 days.

Other: Cigarette use

Control group

Subjects with no history of prior conventional cigarette (\< 100 cigarettes lifetime) or electronic cigarette use.

Other: Control group

Interventions

Electronic cigarette useOTHER

Subjects who use electronic cigarettes daily and have not used conventional cigarettes in the previous 3 months.

E Cigarette users
Cigarette useOTHER

Subjects who smoke at least ¼ pack cigarettes per day for the past 1 year, with no history of electronic cigarette use in the last 30 days.

Cigarette smokers
Control groupOTHER

Subjects with no history of prior conventional cigarette (\< 100 cigarettes lifetime) or electronic cigarette use.

Control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy subjects, including electronic cigarette users, cigarette smokers and controls will be recruited.

You may qualify if:

  • \. Healthy subjects less than 45 years of age and BMI \< 35

You may not qualify if:

  • Age \< 18 years
  • Pregnant or Breast-Feeding
  • Participation in a clinical trial of an investigational medicinal product within 30 days
  • Consent declined
  • History of asthma
  • Marijuana use or other inhaled products with or without nicotine in the last 3 months
  • Alcohol abuse, as defined by the Alcohol Use Disorders Identification Test (AUDIT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queens University

Belfast, Northern Ireland, BT 9, United Kingdom

RECRUITING

Related Publications (6)

  • Rutten LJ, Blake KD, Agunwamba AA, Grana RA, Wilson PM, Ebbert JO, Okamoto J, Leischow SJ. Use of E-Cigarettes Among Current Smokers: Associations Among Reasons for Use, Quit Intentions, and Current Tobacco Use. Nicotine Tob Res. 2015 Oct;17(10):1228-34. doi: 10.1093/ntr/ntv003. Epub 2015 Jan 14.

    PMID: 25589678BACKGROUND

  • Lerner CA, Sundar IK, Yao H, Gerloff J, Ossip DJ, McIntosh S, Robinson R, Rahman I. Vapors produced by electronic cigarettes and e-juices with flavorings induce toxicity, oxidative stress, and inflammatory response in lung epithelial cells and in mouse lung. PLoS One. 2015 Feb 6;10(2):e0116732. doi: 10.1371/journal.pone.0116732. eCollection 2015.

    PMID: 25658421BACKGROUND

  • Wu Q, Jiang D, Minor M, Chu HW. Electronic cigarette liquid increases inflammation and virus infection in primary human airway epithelial cells. PLoS One. 2014 Sep 22;9(9):e108342. doi: 10.1371/journal.pone.0108342. eCollection 2014.

    PMID: 25244293BACKGROUND

  • Sussan TE, Gajghate S, Thimmulappa RK, Ma J, Kim JH, Sudini K, Consolini N, Cormier SA, Lomnicki S, Hasan F, Pekosz A, Biswal S. Exposure to electronic cigarettes impairs pulmonary anti-bacterial and anti-viral defenses in a mouse model. PLoS One. 2015 Feb 4;10(2):e0116861. doi: 10.1371/journal.pone.0116861. eCollection 2015.

    PMID: 25651083BACKGROUND

  • Schober W, Szendrei K, Matzen W, Osiander-Fuchs H, Heitmann D, Schettgen T, Jorres RA, Fromme H. Use of electronic cigarettes (e-cigarettes) impairs indoor air quality and increases FeNO levels of e-cigarette consumers. Int J Hyg Environ Health. 2014 Jul;217(6):628-37. doi: 10.1016/j.ijheh.2013.11.003. Epub 2013 Dec 6.

    PMID: 24373737BACKGROUND

  • Morris PB, Ference BA, Jahangir E, Feldman DN, Ryan JJ, Bahrami H, El-Chami MF, Bhakta S, Winchester DE, Al-Mallah MH, Sanchez Shields M, Deedwania P, Mehta LS, Phan BA, Benowitz NL. Cardiovascular Effects of Exposure to Cigarette Smoke and Electronic Cigarettes: Clinical Perspectives From the Prevention of Cardiovascular Disease Section Leadership Council and Early Career Councils of the American College of Cardiology. J Am Coll Cardiol. 2015 Sep 22;66(12):1378-91. doi: 10.1016/j.jacc.2015.07.037.

    PMID: 26383726BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken at initially for screening then at baseline, 24 hours after first bronchoscopy, prior to the inhalation of LPS 6 weeks later and 24 hours post LPS inhalation. Urine sample will be collected before both camera tests. Bronchoalveolar lavage fluid will be taken at baseline then 6 weeks later.

MeSH Terms

Conditions

Acute Lung InjuryPneumoniaVaping

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfectionsSmokingBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Murali Shyamsundar, PhD

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Murali Shyamsundar, PhD

CONTACT

02890 976381murali.shyamsundar@qub.ac.uk

Philip Toner, MBBcH

CONTACT

02890 976381ptoner09@qub.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer and Consultant in Intensive Care Medicine

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 15, 2016

Study Start

February 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)