EmphysemaPhase 4NCT03382106
Smoking Cessation and Functional CT Assessment
A Phase 4 study testing Sildenafil 20 MG, Pulse wave velocity and Carotid artery compliance and stiffness in people with Emphysema, run by Eric A. Hoffman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emphysema
- What is being tested?
- Sildenafil 20 MG, Pulse wave velocity and Carotid artery compliance and stiffness
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 24 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Smoking Cessation and Functional CT Assessment of Pulmonary Arterial Dysfunction in Smoking Associated Emphysema
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.
Read the 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
- Being tested
- Sildenafil 20 MG, Placebo Oral Tablet, Pulse wave velocity, Carotid artery compliance and stiffness, Pressure wave reflection
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 20 MGDrug
Also called Experimental: Smoking Cessation Group 1, Experimental: Non-Smokers Group 1
Sildenafil, 20mg three times daily for 3 month period.
Placebo Oral TabletDrug
Also called No Intervention: Smoking Cessation Group 2
Placebo manufactured to look like Sildenafil 20 MG
Pulse wave velocityDiagnostic test
Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.
Carotid artery compliance and stiffnessDiagnostic test
An echocardiogram is done by using a probe placed on the skin.
Pressure wave reflectionDiagnostic test
Carotid pulse measurement taken using a tonometer probe
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation Group 1 | Experimental | 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. Receives: Drug: Sildenafil 20 MG; Diagnostic Test: Pulse wave velocity; Diagnostic Test: Carotid artery compliance and stiffness; Diagnostic Test: Pressure wave reflection |
| Smoking Cessation Group 2 | Placebo comparator | 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. Receives: Drug: Placebo Oral Tablet; Diagnostic Test: Pulse wave velocity; Diagnostic Test: Carotid artery compliance and stiffness; Diagnostic Test: Pressure wave reflection |
| Non-Smokers Group 1 | Experimental | 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. Receives: Drug: Sildenafil 20 MG; Diagnostic Test: Pulse wave velocity; Diagnostic Test: Carotid artery compliance and stiffness |
| Non-Smokers Group 2 | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure and compare individual smokers' responses to smoking cessation, Sildenafil and placebo with lung imaging to determine decrease of inflammation and increase of blood flow in lungs.
Our outcome measure is the change in regional blood volume between baseline and interventions with CT imaging, sildenafil/placebo and smoking cessation.
Measured: 90 Days
Secondary outcomes (3)
Pulse wave velocity of carotid radial, brachial, femoral and carotid arteries
Our outcome measure is the difference of arterial stiffness between baseline and 90 day visits.
Measured: Baseline and 90 day
Carotid beta-stiffness index
Our outcome measure is the difference of common carotid artery stiffness between baseline and 90 day visits
Measured: Baseline and 90 Day
Carotid augmentation index
Our outcome measure is the difference of pressure wave reflection between baseline and 90 day visits
Measured: Baseline and 90 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start19 Mar 2018
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric A. Hoffman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Eric A. Hoffman, University of Iowa
- Investigators
- Eric Hoffman, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382106
- Sponsor's protocol ID
- 201706713
- Other IDs
- R01HL130883
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2017
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation and Functional CT Assessment of Pulmonary Arterial Dysfunction in Smoking Associated Emphysema
- ClinicalTrials.gov ID
- NCT03382106
- Acronym / sponsor ID
- 201706713
- Conditions
- Emphysema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Eric A. HoffmanUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Group 1 | Experimental | Drug: Sildenafil 20 MG, Diagnostic Test: Pulse wave velocity, Diagnostic Test: Carotid artery compliance and stiffness, Diagnostic Test: Pressure wave reflection80 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. |
| Smoking Cessation Group 2 | Placebo comparator | Drug: Placebo Oral Tablet, Diagnostic Test: Pulse wave velocity, Diagnostic Test: Carotid artery compliance and stiffness, Diagnostic Test: Pressure wave reflection80 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. |
| Non-Smokers Group 1 | Experimental | Drug: Sildenafil 20 MG, Diagnostic Test: Pulse wave velocity, Diagnostic Test: Carotid artery compliance and stiffness20 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. |
| Non-Smokers Group 2 | No intervention | –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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil 20 MGAlso: Experimental: Smoking Cessation Group 1, Experimental: Non-Smokers Group 1Sildenafil, 20mg three times daily for 3 month period. | Drug | Non-Smokers Group 1, Smoking Cessation Group 1 |
| Placebo Oral TabletAlso: No Intervention: Smoking Cessation Group 2Placebo manufactured to look like Sildenafil 20 MG | Drug | Smoking Cessation Group 2 |
| Pulse wave velocityVascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe. | Diagnostic test | Non-Smokers Group 1, Smoking Cessation Group 1, Smoking Cessation Group 2 |
| Carotid artery compliance and stiffnessAn echocardiogram is done by using a probe placed on the skin. | Diagnostic test | Non-Smokers Group 1, Smoking Cessation Group 1, Smoking Cessation Group 2 |
| Pressure wave reflectionCarotid pulse measurement taken using a tonometer probe | Diagnostic test | Smoking Cessation Group 1, Smoking Cessation Group 2 |
Primary outcome
Measure and compare individual smokers' responses to smoking cessation, Sildenafil and placebo with lung imaging to determine decrease of inflammation and increase of blood flow in lungs.
Time frame: 90 Days
Our outcome measure is the change in regional blood volume between baseline and interventions with CT imaging, sildenafil/placebo and smoking cessation.
3 secondary outcomes
Pulse wave velocity of carotid radial, brachial, femoral and carotid arteries
Time frame: Baseline and 90 day
Carotid beta-stiffness index
Time frame: Baseline and 90 Day
Carotid augmentation index
Time frame: Baseline and 90 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Yes. CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hoffman, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil 20 MG, Pulse wave velocity and Carotid artery compliance and stiffness in people with Emphysema, run by Eric A. Hoffman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and compare individual smokers' responses to smoking cessation, Sildenafil and placebo with lung imaging to determine decrease of inflammation and increase of blood flow in lungs. (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.