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The Study of ELEctronic Cigarette Toxicity in a Human Model in Vivo Model of Inflammation and Vascular Dysfunction (SELECT)

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ClinicalTrials.gov Identifier: NCT02739438
Recruitment Status : Unknown
Verified April 2016 by Murali Shyamsundar, Queen's University, Belfast.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2016
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Murali Shyamsundar, Queen's University, Belfast

Brief Summary:
The 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.

Condition or disease Intervention/treatment
Acute Lung Injury Other: Electronic cigarette use Other: Cigarette use Other: Control group

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study of ELEctronic Cigarette Toxicity in a Human Model in Vivo Model of Inflammation and Vascular Dysfunction (SELECT)
Study Start Date : May 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017


Group/Cohort Intervention/treatment
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
Subjects who use electronic cigarettes daily and have not used conventional cigarettes in the previous 3 months.

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
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.

Control group
Subjects with no history of prior conventional cigarette (< 100 cigarettes lifetime) or electronic cigarette use.
Other: Control group
Subjects with no history of prior conventional cigarette (< 100 cigarettes lifetime) or electronic cigarette use.




Primary Outcome Measures :
  1. bronchoalveolar lavage neutrophil count in response to LPS stimulation [ Time Frame: BAL 6 hours after LPS inhalation ]

Secondary Outcome Measures :
  1. Alveolar inflammatory response [ Time Frame: 24 hours after LPS inhalation ]
    1. Alveolar inflammatory response biomarkers which may include but are not limited to the measurement of BAL cytokines (including but not limited to TNFα, IL1β, IL6, IL8), proteases and antiproteases, HO1, coagulation factors (including but not limited to thrombin-antithrombin complex, tissue factor, protein C, thrombomodulin and plasminogen activator inhibitor1), and RAGE ligands. Identification of specific cellular populations within the BAL (using but not limited to cytospins, flow cytometry, ELISpot assays, in vitro cell expansion).

  2. Plasma inflammatory response [ Time Frame: 24 hours after LPS inhalation ]
    Plasma inflammatory response biomarkers which may include but are not limited to measurement of plasma CRP, cytokines (including but not limited to TNFα, IL1β, IL6, IL8), proteases and antiproteases, HO1, adhesion and activation molecule expression (including but not limited to sICAM1), coagulation factors (including but not limited to thrombin-antithrombin complex, tissue factor, protein C, thrombomodulin and plasminogen activator inhibitor1), and RAGE ligands.

  3. Indices of alveolar epithelial and endothelial and injury [ Time Frame: 24 hours after LPS inhalation ]
    Intracellular signalling activity in the alveolar space which may include but not limited to the measurement of BAL total and phosphorylated p38, ERK and JNK MAPKs and STAT -1/-3 from leucocyte extracts. Activated and total IκBα and β will be measured in cytoplasmic extracts and NFκβ and AP-1 in nuclear extracts.

  4. 4. FMD of brachial artery as a marker of the effects of e-cigarettes on endothelial function [ Time Frame: 5 mins within use of an electronic cigarette ]
    FMD of brachial artery to study endothelial dysfunction.


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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy subjects, including electronic cigarette users, cigarette smokers and controls will be recruited.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739438


Contacts
Contact: Murali Shyamsundar, PhD 02890 976381 murali.shyamsundar@qub.ac.uk
Contact: Philip Toner, MBBcH 02890 976381 ptoner09@qub.ac.uk

Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Murali Shyamsundar, PhD Queen's University, Belfast

Publications:

Responsible Party: Murali Shyamsundar, Senior lecturer and Consultant in Intensive Care Medicine, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT02739438     History of Changes
Other Study ID Numbers: B16/28
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Murali Shyamsundar, Queen's University, Belfast:
Pulmonary inflammation
Endothelial dysfunction
Electronic Cigarettes

Additional relevant MeSH terms:
Inflammation
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders