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Functional CT Assessment for Emphysema
Phase 4
Recruiting
Led By Eric A 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 pre hypoxic breathing and 15 minutes post hypoxic breathing
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial will use DECT to see if there is a relationship between different types of perfusion, hypoxia, and the widening of pulmonary arteries in smokers to emphysema.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to hypoxia or hyperoxia exposure such as dizziness or shortness of breath. Sildenafil could cause headaches, flushing, indigestion, visual disturbances, and in rare cases serious cardiovascular events.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre sildenafil adminstration and one hour after sildenafil adminstration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre sildenafil adminstration and one hour after sildenafil adminstration.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Perfused blood volume assessed pre and post hyperoxic breathing
Perfused blood volume assessed pre and post hypoxic breathing
Blood Volume
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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
3Treatment groups
Experimental Treatment
Group I: SildenafilExperimental Treatment1 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.
Group II: Hypoxia Administration study groupExperimental Treatment1 Intervention
40 subjects will be recruited to study normoxia oxygen compared to hypoxia oxygen. 20M and 20F subjects will be evaluated under normoxia oxygen with low dose non-contrast CT scans at total lung capacity (TLC) and 20% vital capacity (VC) and then with contrast using dual energy CT scans to evaluate heterogeneity of perfused blood volume (PBV). For the intervention, following the normixia scans, hypoxia administration will be administered by breathing an inspired FIO2 of 15% oxygen and the non-contrast and contrast using DECT scans to evaluate heterogeneity of perfused blood volumen will be completed.
Group III: Hyperoxia Administration study groupExperimental Treatment1 Intervention
40 subjects will recruited to study normoxia oxygen scans compared to hyperoxia scans. 20M and 20F subjects will be evaluated under normoxia with low dose non-contrast CT scans at TLC and 20% vital capacity (VC) and then with contrast scans using DECT to evaluate heterogeneity of perfused blood volume (PBV). For the intervention, following the normoxia scans, hyperoxia administration will be administered by breathing an inspired FIO2 of 100% oxygen and the non-contrast and contrast using DECT to evaluate heterogeneity of perfused blood volumen will be completed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil
FDA approved
Find a Location
Who is running the clinical trial?
Eric A. HoffmanLead Sponsor
4 Previous Clinical Trials
661 Total Patients Enrolled
2 Trials studying Emphysema
302 Patients Enrolled for Emphysema
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,553 Total Patients Enrolled
8 Trials studying Emphysema
1,259 Patients Enrolled for Emphysema
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,921 Previous Clinical Trials
47,760,542 Total Patients Enrolled
24 Trials studying Emphysema
20,890 Patients Enrolled for Emphysema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.Your body mass index (BMI) is higher than 32.You have a history of heart disease, kidney disease, or diabetes.You have been diagnosed with asthma.You have a serious disease in any major organ system, according to the study medical team's judgment.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.Your lung function test results need to show that your breathing is not restricted, and that your lungs are working well.You weigh more than 220 pounds (100 kilograms).You are allergic to shellfish, seafood, eggs, or iodine.You're taking certain medications for your heart or lungs, but not aspirin, high blood pressure, or digestive issues.You have metal inside or on your body from your nose to your abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperoxia Administration study group
- Group 2: Hypoxia Administration study group
- Group 3: Sildenafil
Awards:
This trial has 5 awards, including:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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