Smoking Cessation and Functional CT Assessment

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eric A. Hoffman
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria (Smokers):

• 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 ½ 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: FEV1≥0.80 and FEV1/FVC>0.70 Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC)

• GOLD 1: FEV1≥0.80 and FEV1/FVC < 0.70

• GOLD 2: 0.50≤FEV1<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: FEV1≥0.80 and FEV1/FVC>0.70

Exclusion Criteria (Smokers and Non-smokers):

• 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.