Status:
COMPLETED
Smoking Cessation and Functional CT Assessment
Lead Sponsor:
Eric A. Hoffman
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Emphysema
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
The purpose of this research study is to find out if smoking cessation combined with sildenafil, an FDA approved drug for pulmonary hypertension, will decrease inflammation in the lung. Even if a smok...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Smokers):
- Between the age of 21 to 65 at baseline
- Be willing to participate in a smoking cessation program
- Be willing to attend all clinic visits
- Must be currently smoking at least ½ pack/day at baseline (confirmed with cotinine level and CO Smokerlyzer)
- \>5 pack-year history of smoking
- Global Initiative for Chronic Obstructive Lung Disease (GOLD) 0: FEV1≥0.80 and FEV1/FVC\>0.70 Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC)
- GOLD 1: FEV1≥0.80 and FEV1/FVC \< 0.70
- GOLD 2: 0.50≤FEV1\<0.80 and FEV1/FVC \< 0.70
- Be willing to abstain from using any nicotine patches, e-cigarettes, or marijuana for the duration of the study.
- Inclusion Criteria (Non-smokers):
- Between the age of 21 to 65 at baseline
- Be willing to attend all clinic visits
- Have never smoked (confirmed with cotinine level and CO smokerlyzer)
- GOLD 0: FEV1≥0.80 and FEV1/FVC\>0.70
- Exclusion Criteria (Smokers and Non-smokers):
- Women only: Cannot be pregnant or nursing at baseline or plan to become pregnant during the course of the study
- Body Mass Index (BMI) \> 35
- Allergies to shell fish, seafood, eggs or iodine
- Heart disease, kidney disease or diabetes
- Diagnosis of asthma
- Any metal in or on the body (that cannot be removed) between the nose and the abdomen
- Any major organ system disease (by judgment of the study medical team)
- A glomerular filtration rate of 60 cc per minute or less.
- Nitroglycerin usage or nitrates and use of phosphodiesterase 5 (PDE5) inhibitors
- Prior history of hypersensitivity to sildenafil
- Currently prescribed a phosphodiesterase (PDE) inhibitors medication (ex: Viagra, Cialis, etc)
- Known Pulmonary Hypertension
- Has used e-cigarettes and marijuana \<1 years
- Use of ACE Inhibitors, Calcium Channel Blockers, Angiotensin II Receptor Blockers for control of blood pressure or any combination of these three types of medications.
Exclusion
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT03382106
Start Date
March 19 2018
End Date
September 24 2024
Last Update
February 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242