Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs (NCT03691350) | Clinical Trial Compass
CompletedEarly Phase 1
Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs
United States66 participantsStarted 2018-09-17
Plain-language summary
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.
Who can participate
Age range21 Years – 52 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
What they're measuring
1
Changes in Cytokines
Timeframe: Baseline to day 71
2
Changes in Cell Counts
Timeframe: Baseline to day 71
Trial details
NCT IDNCT03691350
SponsorOhio State University Comprehensive Cancer Center