Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03382106
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03382106
Study Brief:
Protocol Section:
NCT03382106