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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how blood flow in the lungs affects smokers who may be prone to emphysema, a lung condition. Researchers use special CT scans to determine if increasing oxygen (hyperoxia administration) or using a medication called Sildenafil can improve lung health. Participants will be divided into groups to test different treatments. Smokers with mild breathing issues who can stop smoking temporarily are a good fit for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand how it benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that affect the heart or lungs, but some medications like contraceptives, anti-depressants, and aspirin are allowed. It's best to discuss your specific medications with the study team.

What is the safety track record for these treatments?

Research has shown that sildenafil, a common medication, is generally safe for individuals with certain lung conditions. Although studies indicate it doesn't significantly improve exercise ability in those with emphysema, it is usually well-tolerated. However, it might slightly affect lung function in some individuals with Chronic Obstructive Pulmonary Disease (COPD), which includes emphysema.

The FDA has already approved sildenafil for treating other conditions, such as high blood pressure in the lungs, supporting its safety profile. As with any treatment, potential side effects may occur, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores how sildenafil, a drug traditionally used for erectile dysfunction, could offer new insights into treating emphysema. Unlike standard treatments for emphysema such as bronchodilators and steroids, which mainly focus on relieving symptoms and reducing inflammation, sildenafil may enhance blood flow in the lungs by targeting blood vessels directly. This unique mechanism of action could potentially improve lung function and quality of life for patients with emphysema. By assessing perfused blood volume in the lungs after sildenafil administration, the study aims to uncover new ways to manage this challenging condition more effectively.

What evidence suggests that this trial's treatments could be effective for emphysema?

Research has shown that sildenafil, which participants in this trial may receive, can help with certain lung issues related to emphysema. Studies have found that it can increase the distance patients can walk in six minutes, indicating improved exercise ability. Patients using sildenafil have also experienced a decrease in pressure in their lung blood vessels and improvements in their BODE index, a measure of lung disease severity. Although using sildenafil for emphysema without high blood pressure in the lungs hasn't shown benefits, it appears promising for related conditions. Overall, sildenafil is considered safe and effective for improving certain lung functions. ^{1 2 3 4 6}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4904720/

Sildenafil for Chronic Obstructive Pulmonary Disease Routine sildenafil administration did not have a beneficial effect on exercise capacity in patients with COPD and emphysema without pulmonary hypertension.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0344033825002900

Efficacy of sildenafil combined with statins in treating ... Sildenafil significantly improved exercise capacity, with a mean increase in 6-minute walk distance (6MWD) of 29.64 m (95 % CI: 13.78–45.50; *p*<0.001), and ...

3. publications.ersnet.org publications.ersnet.org/content/erj/42/4/982

Sildenafil to improve respiratory rehabilitation outcomes in ... Our study is the first long-term, double-blind, placebo-controlled trial assessing the effects of targeted therapy in patients with COPD and increased PAP.

4. phassociation.org phassociation.org/ph-with-copd-is-sildenafil-an-effective-treatment-option/

PH with COPD: Is Sildenafil an Effective Treatment Option? At the end of the 16-week study, the authors found that patients in the sildenafil group had reduced PVR and their BODE index had improved.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32634428/

Efficacy and safety of Sildenafil treatment in pulmonary ... Available clinical evidence indicates that Sildenafil seems to be safe and effective for COPD-PH and can improve the patients' 6WMD.

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa1002110

A Controlled Trial of Sildenafil in Advanced Idiopathic ... According to available safety and efficacy data for sildenafil at the time that the protocol was designed, a response rate of 30% with ...