Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs

The Ohio State University

Status and phase: Enrolling; Early Phase 1

Conditions: Cigarette Smoker; Current Every Day Smoker

Treatments: Other: Laboratory Biomarker Analysis; Drug: Cigarette; Procedure: Bronchoscopy with Bronchoalveolar Lavage; Other: Electronic Cigarette; Drug: Nicotine Replacement; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03691350

NCI-2018-00283 (Registry Identifier)

OSU-18044

U01DA045530 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This trial studies biomarkers obtained by bronchoscopy (bronchoalveolar lavage and lung brushings) to determine the effect of smoking e-cigarettes on the lungs. Studying samples of lung cells from participants who smoke e-cigarettes may help doctors learn more about changes that occur in deoxyribonucleic acid and identify biomarkers related to cancer.

Full description

PRIMARY OBJECTIVES:

I. To assess inflammatory changes over 10 weeks for lung and urine biomarkers in smokers who undergo serial bronchoscopy. The randomized trial includes four conditions: continued use (n=32), complete switching to the nicotine standardized research electronic cigarettes (e-cig) (SREC) (n=32), complete switching to the placebo (nicotine free) SREC (n=32), and complete switching to nicotine replacement therapy (NRT)(n=32).

OUTLINE: Participants are randomized to 1 of 4 groups.

GROUP I: Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71.

GROUP II: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71.

GROUP III: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71.

GROUP IV: Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71.

After completion of study, participants are followed up at 3 months.

Enrollment: 239 estimated patients

Sex: All

Ages: 21 to 52 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Smokers who smoke >= 5 filtered cigarettes/day for >= 1 year
• No unstable or significant medical conditions as determined by medical history to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures
• Able to read adequately to complete the survey and related study documents or give consent
• Subject has provided written informed consent to participate in the study

Exclusion criteria

• Regular consumption of roll your own cigarettes
• Immune system disorders requiring medication
• Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic obstructive pulmonary disease [COPD], chronic bronchitis, and restrictive lung disease)
• Acute bronchitis or pneumonia within 1 year
• Reported history of diagnosed kidney or liver disease
• Any medical disorder that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use
• General anesthesia within 1 year
• Regular use of inhalant medications in the last 2 months
• Use of antibiotics in prior 30 days
• Use of steroids, including corticosteroids, in prior 30 days
• Allergies to study medications, such as, lidocaine, Versed, fentanyl or Cetacaine
• Allergies to propylene glycol/glycerin or flavors
• History of hypersensitivity to varenicline
• Bronchoscopy or any other lung procedure for any reason within the previous 6 months
• Current or recent (within three months) alcohol or drug abuse problems
• Regularly smoked marijuana within the prior 3 months
• Use of an e-cigarette or other combustible tobacco products in the prior 3 months
• Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product) or intention to quit in next three months
• Adverse reaction to previous e-cig use
• Body mass index (BMI) > 40 (risk of unstable airway)
• Pregnant or breastfeeding - if the subject is female, a urine pregnancy test at no cost to the subject will be done on the day of bronchoscopy
• Unable to read for comprehension or completion of study documents

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 4 patient groups

Group I (usual cigarette brand)

Active Comparator group

Description:

Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Bronchoscopy with Bronchoalveolar Lavage

Other: Questionnaire Administration

Drug: Cigarette

Group II (SREC with nicotine)

Experimental group

Description:

Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Electronic Cigarette

Procedure: Bronchoscopy with Bronchoalveolar Lavage

Other: Electronic Cigarette

Other: Questionnaire Administration

Group III (SREC without nicotine)

Experimental group

Description:

Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week after bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Electronic Cigarette

Procedure: Bronchoscopy with Bronchoalveolar Lavage

Other: Electronic Cigarette

Other: Questionnaire Administration

Group IV (Nicotine Replacement Therapy [NRT])

Experimental group

Description:

Participants undergo bronchoscopy over 30-60 minutes at baseline. One week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Bronchoscopy with Bronchoalveolar Lavage

Drug: Nicotine Replacement

Other: Questionnaire Administration