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Phosphodiesterase-5 (PDE-5) Inhibitor

Sildenafil for Lung Health in Smokers

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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,833,927 Total Patients Enrolled
24 Trials studying Emphysema
20,690 Patients Enrolled for Emphysema
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,231 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
~7 spots leftby Dec 2024
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