Functional CT Assessment for Emphysema

Overseen By Sue E Salisbury, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Eric A. Hoffman

Must not be taking: Heart medications, Lung medications

Disqualifiers: Pregnancy, High BMI, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will use dual energy x-ray computed tomography (DECT) to evaluate the relationship between heterogeneous perfusion, hypoxia (low oxygen in inspired gas) and induction of pulmonary vascular dilatation to characterize emphysema susceptibility in a normal smoking population. The investigators will correlate DECT measures of perfusion with lung injury measured by single photon emission computed tomography (SPECT). 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

Who Is on the Research Team?

Eric A Hoffman, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for current smokers aged 25-65 with specific lung function test results, indicating either normal or mildly impaired lungs. It's not for pregnant/breastfeeding women, those overweight (BMI>32), with heart/kidney/diabetes issues, asthma, severe kidney dysfunction, allergies to certain substances like shellfish or iodine, and those on heart/lung-affecting meds.

Inclusion Criteria

Must be able to give informed consent for self

You must be between 25 and 65 years old.

You must currently be smoking at least half a pack of cigarettes per day, as confirmed by a test for cotinine.

Exclusion Criteria

Pregnant or breastfeeding females

Your kidneys are not filtering blood well, with a rate of 60 cc per minute or less.

If you are taking nitroglycerin or other nitrates, or if you have used certain medications for erectile dysfunction within the last 7 days, you cannot participate. Also, if you are allergic to Sildenafil, you cannot participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Non-contrast imaging at TLC and 20%VC and with contrast using DECT scans to assess perfused blood volume

1 day

1 visit (in-person)

Intervention

Administration of 20 mg of sildenafil followed by repeated DECT scanning one hour after administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperoxia administration study group
• Hypoxia administration study group
• Sildenafil

Trial Overview The study tests how low oxygen (hypoxia) and high oxygen (hyperoxia) conditions affect blood flow in the lungs using special CT scans. It also looks at whether a drug called Sildenafil can improve signs of lung damage in smokers prone to emphysema by dilating pulmonary arteries.

How Is the Trial Designed?

Group I: Sildenafil Experimental Treatment 1 Intervention

40 subjects (20M and 20F) will be recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT scans to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of sildenafil and then the same scanning will be repeated one hour after sildenafil administration.

Who Is Running the Clinical Trial?

Eric A. Hoffman

Lead Sponsor

Trials

5

Recruited

620+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+