Smoking Cessation and Functional CT Assessment

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    280
  • sponsor
    Eric A. Hoffman
Updated on 2 March 2022
COPD
pulmonary disease
forced expiratory volume
sildenafil
cotinine
sildenafil 20 mg
Accepts healthy volunteers

Summary

The investigators will study the effect of pulmonary arterial vasodilation to see if it eliminates indices of persistent lung injury in smokers that are susceptible to emphysema.

Description

The purpose of this research study is to find out if smoking cessation combined with sildenafil, an FDA approved drug for pulmonary hypertension, will decrease inflammation in the lung. Even if a smoker stops smoking, the harmful effects caused by previous smoking may recruit inflammatory cells to those affected areas, leading to lung injury. In about 30-40% of smokers, this inflammation combined with irregular blood flow in the lungs may lead to emphysema. The study goal is to measure and compare individual responses to smoking cessation, Sildenafil and placebo used three times per day, and imaging of the lungs using non-contrast and contrast CT scans to see if there is a possible decrease of inflammation and an increase of blood flow in the lungs. The study also intends to see if using Sildenafil three times per day, in addition to smoking cessation will restore blood flow to the possible injured areas of the lungs. Sildenafil is an FDA approved medication for pulmonary hypertension but will be used off-label to study the effects it may or may not have on the blood flow in possible injured areas of the lungs. Non-smokers will be enrolled to compare lung imaging and the effects of Sildenafil on their lungs with that of smokers undergoing a smoking cessation program with placebo or Sildenafil. Non-smokers will complete identical measurements as smokers, with Sildenafil used three times per day or no medication across a similar 90 day period of time. Vascular measurements of pulse wave velocity, carotid artery compliance/stiffness and pressure wave reflection will be done at baseline and 90 day visits.

Details
Condition Emphysema
Treatment Placebo Oral Tablet, Pulse Wave Velocity, Sildenafil 20 MG, Carotid artery compliance and stiffness, Pressure wave reflection
Clinical Study IdentifierNCT03382106
SponsorEric A. Hoffman
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Between the age of 21 to 65 at baseline
Be willing to participate in a smoking cessation program
Be willing to attend all clinic visits
Must be currently smoking at least pack/day at baseline (confirmed with cotinine level and CO Smokerlyzer)
>5 pack-year history of smoking
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 0: FEV10.80 and FEV1/FVC>0.70 Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC)
GOLD 1: FEV10.80 and FEV1/FVC < 0.70
GOLD 2: 0.50FEV1<0.80 and FEV1/FVC < 0.70
Be willing to abstain from using any nicotine patches, e-cigarettes, or marijuana for the duration of the study
Inclusion Criteria (Non-smokers)
Between the age of 21 to 65 at baseline
Be willing to attend all clinic visits
Have never smoked (confirmed with cotinine level and CO smokerlyzer)
GOLD 0: FEV10.80 and FEV1/FVC>0.70

Exclusion Criteria

Women only: Cannot be pregnant or nursing at baseline or plan to become pregnant during the course of the study
Body Mass Index (BMI) > 35
Allergies to shell fish, seafood, eggs or iodine
Heart disease, kidney disease or diabetes
Diagnosis of asthma
Any metal in or on the body (that cannot be removed) between the nose and the abdomen
Any major organ system disease (by judgment of the study medical team)
A glomerular filtration rate of 60 cc per minute or less
Nitroglycerin usage or nitrates and use of phosphodiesterase 5 (PDE5) inhibitors
Prior history of hypersensitivity to sildenafil
Currently prescribed a phosphodiesterase (PDE) inhibitors medication (ex: Viagra, Cialis, etc)
Known Pulmonary Hypertension
Has used e-cigarettes and marijuana <1 years
Use of ACE Inhibitors, Calcium Channel Blockers, Angiotensin II Receptor Blockers for control of blood pressure or any combination of these three types of medications
Clear my responses

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