Adverse Airway Effects From Tobacco and E-Cigarettes

NCT03251053 | Unknown FDA Device

• 1 other identifier: 1251.09
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study conducted at VA Medical Center in Miami is to determine if smoking electronic cigarettes (known as e-cigarettes) that contain nicotine have less negative effects than regular cigarettes on the person's respiratory health. We will assess this by measuring pulmonary function tests, several body molecules and functionality of the airway cells. We will also evaluate how smokers can maintain exclusive electronic cigarettes use. In this study, some people will continue to smoke regular tobacco cigarettes while others will switch to a nicotine-containing electronic cigarette.

Conditions

Airway Morbidity; Smoking Cessation; Nicotine Adverse Reaction; Smoking, Tobacco; Smoking, Cigarette

Outcome Measures

Primary Outcomes (1)

• Change in nasal potential difference (NPD)

  nasal potential difference (NPD) before and after replacing tobacco cigarettes with electronic cigarettes

  11 weeks of transitioning

Secondary Outcomes (1)

• change in Inflammatory markers smoking to electronic cigarettes

  11 weeks of transitioning

Study Arms (2)

Electronic cigarette use

EXPERIMENTAL

Subjects who try to switch to electronic cigarettes (EC) and subjects who successfully switch to EC.

Device: Electronic cigarette use

Control regular cigarette smokers

OTHER

Habitual smokers without EC use

Device: Electronic cigarette use; Other: Control regular cigarette smokers

Interventions

Electronic cigarette use DEVICE

Replacement of tobacco smoking with electronic cigarette vaping

Control regular cigarette smokers; Electronic cigarette use

Control regular cigarette smokers OTHER

Control regular cigarette smokers

Eligibility Criteria

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

You may qualify if:

• Subjects that actively smoke and have a history of at least 5 pack-years

You may not qualify if:

• HIV,marijuana use, asthma and other concomitant inflammatory pulmonary disorders, subjects with known pulmonary diseases including malignancies, subjects with prior thoracic surgery and subjects that used oral corticosteroids or antibiotics within the prior 3 months, subjects with allergies to study medications and subjects incapable of providing informed consent.

Sponsors & Collaborators

• Miami VA Healthcare System: lead

Study Sites (1)

Miami VA Healthcare System

Miami, Florida, 33125, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking; Cigarette Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Study Officials

• Michael Campos

  Miami VA Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Campos, MD

CONTACT

mcampos1@med.miami.edu

Andrea Guerrero

CONTACT

amg475@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 16, 2017
• Study Start: March 28, 2016
• Primary Completion: March 28, 2021
• Study Completion: March 28, 2021
• Last Updated: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)