Adverse Airway Effects From Tobacco and E-Cigarettes

Smoking Cessation Clinical Trial

Official title:

Adverse Airway Effects of Inhaled Nicotine From Tobacco and E-Cigarettes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251053
• Other study ID #: 1251.09
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2017
• Last updated: August 11, 2017
• Start date: March 28, 2016
• Est. completion date: March 28, 2021

Study information

• Verified date: August 2017
• Source: Miami VA Healthcare System
• Contact: Michael Campos, MD
• Email: mcampos1[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will evaluate the airway epithelial effects of EC (electronic cigarettes) vapor containing nicotine when used as a tobacco replacement tool. By using active cigarette smokers as a comparator group, the study will increase our knowledge of whether the use of ECs is more or less harmful than continuation of tobacco smoking. This study will examine the in vivo effects of EC vapors in nasal ion transport and TGF-β levels as well as in serum inflammatory biomarkers.

As the primary endpoint, nasal ion transport will be assessed by nasal potential difference (NPD), which measures the voltage potential resulting from epithelial ion fluxes at the mucosal surface in vivo. Ion transport across nasal epithelia is representative for findings in distal airways. Since NPD directly measures the changes in ion transport expected to influence mucociliary clearance (MCC) and therefore overall outcome and since changes of NPD measurements are indirectly linked to lung function changes and MCC in trials with cystic fibrosis patients, we believe that NPD lends itself as a reasonable surrogate for MCC for this clinical trial.

As secondary endpoints, we will also measure TGF-ß levels in nasal secretions and expression in nasal cells to correlate these with the level of CFTR and CaCC-mediated Cl- conductance (CFTR is known to show decreased function with elevated TGF-β). In addition plasma samples will be collected to study systemic markers of inflammation as well as toxic substances that may result from vaping and smoking.

The design is a smoking replacement trial, in which we will compare changes in upper airway ion transport and inflammation in smokers who switch to EC vaping versus subjects that continue to smoke tobacco cigarettes. In addition, we will use the trial design to evaluate the feasibility of using the EC as a means to quit tobacco use.

The study will last up to16 weeks with weekly visits. Subjects must replace completely cigarettes with EC within the first 4 visits (week 4) and maintain exclusive use for the following 12 visits. Adherence is asses with exhaled carbon monoxide and/or carboxyhemoglobin when needed. The study involves scheduled blood draws for research samples.

There will be total of 16 visits to the study clinic. Besides blood draws and NPD, the study will include questionnaires, lung function testing and adverse event recording.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 28, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Electronic cigarette use
Replacement of tobacco smoking with electronic cigarette vaping

Other:
• Control regular cigarette smokers

Locations

Country	Name	City	State
United States	Miami VA Healthcare System	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Miami VA Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nasal potential difference (NPD)	nasal potential difference (NPD) before and after replacing tobacco cigarettes with electronic cigarettes	11 weeks of transitioning
Secondary	change in Inflammatory markers smoking to electronic cigarettes	TGF-ß levels in nasal secretions before and after replacing tobacco cigarettes with electronic cigarettes	11 weeks of transitioning