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In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense (Cinimic)

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ClinicalTrials.gov Identifier: NCT03700892
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
While e-cigs are commonly represented as safer alternatives to tobacco cigarettes, little is known regarding the health effects of their short- or long-term use. The responses and the e-cig components exerting these effects on the airways are largely unknown. This study will identify if specific e-cig flavors modify respiratory immune responses. This study will determine the effects of cinnamaldehyde (CA)-containing e-cigarettes on airway epithelial cell ciliary function (i.e., MCC) in humans. Additionally the study will determine the effects of CA-containing e-cigarettes on airway immune cells obtained through induced sputum (SI) after inhalation of CA-containing e-cig aerosols to determine CA-induced effects on a) immune cell function (e.g., phagocytosis, respiratory burst), b) immune cell surface phenotype, and c) mediator production in humans in vivo.

Condition or disease Intervention/treatment Phase
Smoking Healthy Other: Cinnamaldehyde e-liquid Other: PG/VG e-liquid Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Controls will not be randomized and will not receive the study intervention.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The e-liquids will be maintained by an individual not active in the study procedures or analysis.
Primary Purpose: Basic Science
Official Title: In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Cinnamaldehyde, then PG/VG
Participants will inhale cinnamaldehyde e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale Propylene Glycol/Vegetable Glycerin (PG/VG) e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour.
Other: Cinnamaldehyde e-liquid
Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
Other Name: Cinnamon

Other: PG/VG e-liquid
Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
Other Name: Placebo

Experimental: PG/VG, then Cinnamaldehyde
Participants will inhale PG/VG e-liquid in 6, 5-minute paced vaping segments (1 puff/minute) over 1 hour. A 2-3 week washout period will follow. Then participants will inhale cinnamaldehyde e-liquid in 6, 5-minute vaping segments (1 puff/minute) over 1 hour.
Other: Cinnamaldehyde e-liquid
Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
Other Name: Cinnamon

Other: PG/VG e-liquid
Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
Other Name: Placebo




Primary Outcome Measures :
  1. CA-induced changes in MCC [ Time Frame: Through study completion, an average of three months ]
    Percent change as compared to baseline measurement


Secondary Outcome Measures :
  1. Regional lung clearance rates. [ Time Frame: Through study completion, an average of three months ]
    This will assess clearance rates from the central (C) and peripheral (P) regions as secondary endpoints that may reflect differential effects between a region with relatively more (C) vs. less (P) large bronchial airways.

  2. Differential cell counts in CA-induced changes in IS samples [ Time Frame: Through study completion, an average of three months ]
    Percent change of per cell type as compared to baseline

  3. Baseline differences in MCC in non-smokers/non-vapers as compared to e-cigarette users [ Time Frame: Start of study, up to three months ]
    Difference as calculated per MCC clearance rates between non-smokers and non-vapers.


Other Outcome Measures:
  1. CA-Induced changes in immune cell function [ Time Frame: Through study completion, an average of three months ]
    Percent change from baseline in phagocytosis

  2. Peripheral blood mononuclear cell analysis [ Time Frame: Through study completion, an average of three months ]
    Percent change in cell counts as compared to baseline

  3. Blood serum analysis of inflammatory mediators [ Time Frame: Through study completion, an average of three months ]
    Percent change of mediator expression as compared to baseline

  4. CA-Induced changes in Epithelial Lining Fluid [ Time Frame: Through study completion, an average of three months ]
    Pre-vaping session versus post-vaping session expressed as a percent change

  5. CA-Induced changes in Epithelial Lining Fluid 24 hours after vaping session [ Time Frame: Through study completion, an average of three months ]
    Percent change as compared to post-vaping session sample

  6. Changes in Epithelial Lining Fluid [ Time Frame: Through study completion, an average of three months ]
    Percent change as compared to baseline

  7. Tidal volume subjects own e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Tidal Volume in milliliters

  8. Respiratory rate with subjects own e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Respiratory Rate in breaths per minute

  9. Minute ventilation with subjects own e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Minute Ventilation in L/min

  10. Inspiratory flow with subjects own e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Inspiratory flow in L/min

  11. Expiratory flow with subjects own e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Expiratory flow in L/min

  12. Tidal volume with investigator e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Tidal Volume in milliliters

  13. Respiratory rate with investigator e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Respiratory Rate in breaths per minute

  14. Minute ventilation with investigator e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Minute Ventilation in L/min

  15. Inspiratory flow with investigator e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Inspiratory flow in L/min

  16. Expiratory flow with investigator e-cigarette device [ Time Frame: Through study completion, an average of three months ]
    Expiratory flow in L/min



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • An equal number of participants who currently use a vaping device and those who do not use a vaping device
  • Age 18-40
  • Must have a Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁) of at least 80% of predicted. Participants who fall out of the normal range will be offered a copy of the test to share with their personal physician.

Exclusion Criteria:

  • Any pre-existing lung disease (asthma, cystic fibrosis, etc.)
  • Any significant chronic illness, such as, but not limited to, heart disease, uncontrolled hypertension, diabetes, auto-immune disease
  • Any use of tobacco products (other than e-cig) in the past 3 months, or a greater than 10 pack year history of smoking cigarettes
  • Pregnant or nursing women
  • Participants with a history of radiation exposure in the past year which exceeds annual safe limits.

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): NCT03700892


Contacts
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Contact: Carole Robinette, MS 919-843-8472 Carole_Robinette@med.unc.edu

Locations
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United States, North Carolina
UNC Center for Environmental Medicine, Asthma and Lung Biology Recruiting
Chapel Hill, North Carolina, United States, 27599-7310
Contact: Carole Robinette, MS    919-843-8472    carole_robinette@med.unc.edu   
Principal Investigator: Ilona Jaspers, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Ilona Jaspers, PhD University of North Carolina

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03700892     History of Changes
Other Study ID Numbers: 17-2275
R01HL139369 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication
Access Criteria:

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata

Requests for access to individual participant data should be sent to bring44@email.unc.edu or carole.robinette@med.unc.edu. Access will be granted after a data access agreement has been signed with UNC.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
e-cig
E-cigarette
Electronic cigarette
Vaping
Additional relevant MeSH terms:
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Cinnamic aldehyde
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs