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Phosphodiesterase-5 (PDE-5) Inhibitor

Sildenafil for Lung Health in Smokers

Q: How many participants are being monitored for the duration of this clinical trial?

Affirmative. According to the clinicaltrials.gov listing, recruitment for this health study is still ongoing; it was first posted on March 19th 2018 and the details were last updated August 29th 2022. The research team requires a total of 280 patients from 1 medical site.

Q: Are investigators currently accepting participants for this experiment?

Affirmative. The clinicaltrials.gov registry has this trial listed as currently open for recruitment, first posted on March 19th 2018 and last edited August 29th 2022. A total of 280 individuals are needed from 1 site to take part in the study.

Q: Is this research open to elderly volunteers?

Eligible participants for this clinical trial must be 21 years of age or above, with a maximum cap at 65.

Phase 4

Recruiting

Led By Eric Hoffman, PhD

Research Sponsored by Eric A. Hoffman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Study Summary

This trial will study whether relaxing the blood vessels in the lungs can improve lung function in smokers.

Who is the study for?

This trial is for current smokers aged 21-65 who are willing to quit and participate in a smoking cessation program. They must smoke at least half a pack per day, have a history of over five pack-years of smoking, and show certain lung function levels (GOLD 0-2). Participants cannot use nicotine patches, e-cigarettes, or marijuana during the study.Check my eligibility

What is being tested?

The study tests if Sildenafil—a drug that widens blood vessels—can improve lung health in smokers prone to emphysema. It compares Sildenafil with an inactive pill (placebo) using measures like pulse wave velocity and carotid artery stiffness.See study design

What are the potential side effects?

Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness or visual disturbances. However, not everyone will experience these side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Carotid augmentation index

Carotid beta-stiffness index

Structure of brachial artery

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Smoking Cessation Group 1Experimental Treatment4 Interventions

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 II: Non-Smokers Group 1Experimental Treatment3 Interventions

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 III: Non-Smokers Group 2Active Control1 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.

Group IV: Smoking Cessation Group 2Placebo Group4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pulse wave velocity

2012

N/A

~180

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Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,838 Previous Clinical Trials

47,851,374 Total Patients Enrolled

24 Trials studying Emphysema

20,677 Patients Enrolled for Emphysema

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,596 Total Patients Enrolled

8 Trials studying Emphysema

1,059 Patients Enrolled for Emphysema

Eric A. HoffmanLead Sponsor

4 Previous Clinical Trials

461 Total Patients Enrolled

2 Trials studying Emphysema

102 Patients Enrolled for Emphysema

Media Library

Sildenafil (Phosphodiesterase-5 (PDE-5) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03382106 — Phase 4

Emphysema Research Study Groups: Smoking Cessation Group 2, Non-Smokers Group 2, Non-Smokers Group 1, Smoking Cessation Group 1

Emphysema Clinical Trial 2023: Sildenafil Highlights & Side Effects. Trial Name: NCT03382106 — Phase 4

Sildenafil (Phosphodiesterase-5 (PDE-5) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03382106 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What deleterious effects can Carotid artery compliance and stiffness have on individuals?

"Our team at Power have assessed the safety of Carotid artery compliance and stiffness as a 3, since this is Phase 4 - meaning it has already been cleared for use."

Answered by AI

How is Carotid artery compliance and stiffness usually employed to benefit patients?

"Carotid artery compliance and stiffness can be employed to address premature ejaculation, moderate-to-severe NYHA class II or III pulmonary arterial hypertension, as well as general PAH."

Answered by AI

Who is the ideal cohort for this study?

"This clinical trial is actively recruiting 280 adults, aged 21-65 years old - who have been diagnosed with emphysema. In order to participate in the study, individuals must meet Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria of 0: FEV1≥0.80 and FEV1/FVC>0.70 Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), GOLD 2: 0.50≤FEV1<0.80 and FEV1/FVC < 0.70, as well as GOLD 1: FEV"

Answered by AI

How many participants are being monitored for the duration of this clinical trial?

"Affirmative. According to the clinicaltrials.gov listing, recruitment for this health study is still ongoing; it was first posted on March 19th 2018 and the details were last updated August 29th 2022. The research team requires a total of 280 patients from 1 medical site."

Answered by AI

Are investigators currently accepting participants for this experiment?

"Affirmative. The clinicaltrials.gov registry has this trial listed as currently open for recruitment, first posted on March 19th 2018 and last edited August 29th 2022. A total of 280 individuals are needed from 1 site to take part in the study."

Answered by AI