NCT03382106

Smoking Cessation and Functional CT Assessment

Smoking Cessation and Functional CT Assessment of Pulmonary Arterial Dysfunction in Smoking Associated Emphysema

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Eric A. Hoffman · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Emphysema

Interventions

Type	Name	Description
DRUG	Sildenafil 20 MG	Sildenafil, 20mg three times daily for 3 month period.
DRUG	Placebo Oral Tablet	Placebo manufactured to look like Sildenafil 20 MG
DIAGNOSTIC_TEST	Pulse wave velocity	Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.
DIAGNOSTIC_TEST	Carotid artery compliance and stiffness	An echocardiogram is done by using a probe placed on the skin.
DIAGNOSTIC_TEST	Pressure wave reflection	Carotid pulse measurement taken using a tonometer probe

Timeline

• Start date: 2018-03-19
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2017-12-22
• Last updated: 2025-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study