Evaluation of Acute and Subacute Effects of Nicotine Free Electronic Cigarette(NCFE) Vapors

NCT02585791 | Terminated

• 1 other identifier: 20150373
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This aim will examine the acute and subacute exposures to electronic cigarette (EC) vapor generated from e-liquids without nicotine (NFEC) on life-time non smokers subjects by measuring changes in nasal ion transport and TGF-β levels. Nasal ion transport will be assessed by nasal potential difference (NPD). Tumor growth factor (TGF)-β levels (mRNA and protein by ELISA) will be assessed on nasal cells and lavages.

Conditions

Healthy Lifetime Non-smokers

Keywords

electronic cigarette; airway inflammation; nasal potential difference

Outcome Measures

Primary Outcomes (1)

• changes on nasal potential difference (NPD) measurements

  NPD will be measured at baseline and 7 days after the vapor

  before and after 7 days of vapor

Secondary Outcomes (2)

• changes on nasal nitric oxide

  before and after 7 days of vapor

• changes on TGF-ß levels in nasal lavage

  before and after 7 days of vapor

Study Arms (3)

vape NFEC containing 100% PG

EXPERIMENTAL

Subjects will then be instructed how to use the NFEC (eGo-T® with light emitting diode (LED) display) for 1 week of regularly vaping NFEC containing 100% Propylene Glycol . Subjects will be given the eGo-T®, which contains a 1.2 ml refillable cartridge and a 1100 mAh battery with an LED display to record the number of puffs. Subjects will be asked to puff 100x per day (equivalent to \~10-11 cigarettes) for 7 days. We will accept a vaping range of 80-120 times a day.

Other: Propylene Glycol

vape 100% vegetable glycerin -VG

EXPERIMENTAL

Subjects will then be instructed how to use the NFEC (eGo-T® with LED display) for 1 week of regularly vaping NFEC containing 100% VG. Subjects will be given the eGo-T®, which contains a 1.2 ml refillable cartridge and a 1100 mAh battery with an LED display to record the number of puffs. Subjects will be asked to puff 100x per day (equivalent to \~10-11 cigarettes) for 7 days. We will accept a vaping range of 80-120 times a day.

Other: vegetable glycerin

vape PG+VG

EXPERIMENTAL

Subjects will then be instructed how to use the NFEC (eGo-T® with LED display) for 1 week of regularly vaping NFEC containing 50% PG and 50% VG. Subjects will be given the eGo-T®, which contains a 1.2 ml refillable cartridge and a 1100 milliamp hours (mAh) battery with an LED display to record the number of puffs. Subjects will be asked to puff 100x per day (equivalent to \~10-11 cigarettes) for 7 days. We will accept a vaping range of 80-120 times a day.

Other: PG+VG

Interventions

Propylene Glycol OTHER

inhaled Propylene Glycol (PG) by vaporing

vape NFEC containing 100% PG

vegetable glycerin OTHER

inhaled vegetable glycerin (VG) by vaporing

vape 100% vegetable glycerin -VG

PG+VG OTHER

inhaled PG+VG by vaporing

vape PG+VG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be over 18 years of age.
• Healthy life-time non-smokers

You may not qualify if:

• Presence of airflow obstruction (COPD, asthma, bronchiectasis)
• Other concomitant inflammatory pulmonary disorders
• Subjects with known pulmonary malignancies within 5 years
• Subjects with prior thoracic surgery
• Subjects with respiratory infection that required use of oral corticosteroids and/or antibiotics within the prior 3 months
• Subjects with allergies to study medications
• Subjects incapable of providing informed consent.

Sponsors & Collaborators

• University of Miami: lead
• James and Esther King Biomedical Research Program: collaborator

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Propylene Glycol

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Michael Campos, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 23, 2015
• Study Start: February 22, 2017
• Primary Completion: November 11, 2019
• Study Completion: December 11, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

US (1)