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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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

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 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

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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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