Smoking Cessation and Functional CT Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-19

Study Completion Date

2024-09-24

Brief Summary

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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.

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Detailed Description

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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

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Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Subject and study team are masked to which arm subject is assigned (study drug or placebo). Investigational pharmacy will not be masked. For the non-smoker groups, both subjects and the study team will know which group they are assigned to (study drug or no medication).

Study Groups

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Smoking Cessation Group 1

80 normal smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews), between the ages of 21 and 65 will be studied to assess inflammation and heterogeneity of Perfused Blood Volume prior to and following a 3 month smoking cessation program. In 40 of the 80 subjects during the smoking cessation program, we will provide three times per day Sildenafil 20 milligrams (MG) (Viagra) for the full 3 months of the smoking cessation period. We select a three-month cessation program to maximize the likelihood of compliance with cessation yet providing enough time for a resolution of lung injury to take place. Pulse wave velocity, carotid artery compliance and stiffness and pressure wave reflection will be measured.

Group Type EXPERIMENTAL

Sildenafil 20 MG

Intervention Type DRUG

Sildenafil, 20mg three times daily for 3 month period.

Pulse wave velocity

Intervention Type DIAGNOSTIC_TEST

Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.

Carotid artery compliance and stiffness

Intervention Type DIAGNOSTIC_TEST

An echocardiogram is done by using a probe placed on the skin.

Pressure wave reflection

Intervention Type DIAGNOSTIC_TEST

Carotid pulse measurement taken using a tonometer probe

Smoking Cessation Group 2

80 normal smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews), between the ages of 21 and 65 will be studied to assess inflammation and heterogeneity of Perfused Blood Volume prior to and following a 3 month smoking cessation program. In 40 of the 80 subjects during the smoking cessation program, we will provide three times per day placebo oral tablet for the full 3 months of the smoking cessation period. We select a three-month cessation program to maximize the likelihood of compliance with cessation yet providing enough time for a resolution of lung injury to take place. Pulse wave velocity, carotid artery compliance and stiffness and pressure wave reflection will be measured.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo manufactured to look like Sildenafil 20 MG

Pulse wave velocity

Intervention Type DIAGNOSTIC_TEST

Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.

Carotid artery compliance and stiffness

Intervention Type DIAGNOSTIC_TEST

An echocardiogram is done by using a probe placed on the skin.

Pressure wave reflection

Intervention Type DIAGNOSTIC_TEST

Carotid pulse measurement taken using a tonometer probe

Non-Smokers Group 1

20 non-smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews) between the ages of 21 and 65 will be studied to compare the heterogeneity of Perfused Blood Volume with that of smokers for a 3 month period of time. We will provide 10 females and 10 males three times per day Sildenafil 20 milligrams (MG) (Viagra) for the full 3 months.

Group Type EXPERIMENTAL

Sildenafil 20 MG

Intervention Type DRUG

Sildenafil, 20mg three times daily for 3 month period.

Pulse wave velocity

Intervention Type DIAGNOSTIC_TEST

Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.

Carotid artery compliance and stiffness

Intervention Type DIAGNOSTIC_TEST

An echocardiogram is done by using a probe placed on the skin.

Non-Smokers Group 2

20 non-smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews) between the ages of 21 and 65 will be studied to compare the heterogeneity of Perfused Blood Volume with that of smokers for a 3 month period of time. 10 females and 10 males will not receive any medication for the full 3 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sildenafil 20 MG

Sildenafil, 20mg three times daily for 3 month period.

Intervention Type DRUG

Placebo Oral Tablet

Placebo manufactured to look like Sildenafil 20 MG

Intervention Type DRUG

Pulse wave velocity

Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.

Intervention Type DIAGNOSTIC_TEST

Carotid artery compliance and stiffness

An echocardiogram is done by using a probe placed on the skin.

Intervention Type DIAGNOSTIC_TEST

Pressure wave reflection

Carotid pulse measurement taken using a tonometer probe

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Experimental: Smoking Cessation Group 1 Experimental: Non-Smokers Group 1 No Intervention: Smoking Cessation Group 2

Eligibility Criteria

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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 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.

* 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

* 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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes