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Smoking Cessation and Functional CT Assessment

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ClinicalTrials.gov Identifier: NCT03382106
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : July 2, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Eric A. Hoffman, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Emphysema Drug: Sildenafil 20 MG Drug: Placebo Oral Tablet Phase 4

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 smoker stops smoking, the harmful effects caused by previous smoking may recruit inflammatory cells to those affected areas, leading to lung injury. In about 30-40% of smokers, this inflammation combined with irregular blood flow in the lungs may lead to emphysema. The study goal is to measure and compare individual responses to smoking cessation, Sildenafil and placebo used three times per day, and imaging of your lungs using non-contrast and contrast CT scans to see if there is a possible decrease of inflammation and an increase of blood flow in your lungs. The study also intends to see if using Sildenafil three times per day, in addition to smoking cessation will restore blood flow to the possible injured areas of the lungs. Sildenafil is an FDA approved medication for pulmonary hypertension but will be used off-label to study the effects it may or may not have on the blood flow in possible injured areas of the lungs.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Subject and study team are masked to which arm subject is assigned (study drug or placebo). Investigational pharmacy will not be masked.
Primary Purpose: Basic Science
Official Title: Smoking Cessation and Functional CT Assessment of Pulmonary Arterial Dysfunction in Smoking Associated Emphysema
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smoking Cessation Group 1
80 normal smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews), between the ages of 25 and 65 will be studied to assess inflammation and heterogeneity of Perfused Blood Volume prior to and following a 3 month smoking cessation program. In 40 of the 80 subjects during the smoking cessation program, we will provide three times per day Sildenafil 20 milligrams (MG) (Viagra) for the full 3 months of the smoking cessation period. We select a three-month cessation program to maximize the likelihood of compliance with cessation yet providing enough time for a resolution of lung injury to take place.
Drug: Sildenafil 20 MG
Sildenafil, 20mg three times daily for 3 month period.
Other Name: Experimental: Smoking Cessation Group 1

Placebo Comparator: Smoking Cessation Group 2
80 normal smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews), between the ages of 25 and 65 will be studied to assess inflammation and heterogeneity of Perfused Blood Volume prior to and following a 3 month smoking cessation program. In 40 of the 80 subjects during the smoking cessation program, we will provide three times per day placebo oral tablet for the full 3 months of the smoking cessation period. We select a three-month cessation program to maximize the likelihood of compliance with cessation yet providing enough time for a resolution of lung injury to take place.
Drug: Placebo Oral Tablet
Placebo manufactured to look like Sildenafil 20 MG
Other Name: No Intervention: Smoking Cessation Group 2




Primary Outcome Measures :
  1. Dual energy CT determined pulmonary blood volume will be measured in a total of 80 smoking cessation subjects. [ Time Frame: 5 years ]
    Our outcome measure is the change in regional blood volume between baseline and interventions with sildenafil/placebo and smoking cessation.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the age of 25 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.

Exclusion Criteria:

  • Women only: Cannot be pregnant or nursing at baseline or plan to become pregnant during the course of the study
  • Body Mass Index (BMI) > 32
  • Weight > 220 pounds
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382106


Contacts
Contact: Sue E Salisbury, BS 319-356-1810 sue-salisbury@uiowa.edu
Contact: Ann Sieren 319-353-6213 ann-sieren@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Eric A. Hoffman
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Eric Hoffman, PhD Professor
  Study Documents (Full-Text)

Documents provided by Eric A. Hoffman, University of Iowa:
Study Protocol  [PDF] September 11, 2017
Statistical Analysis Plan  [PDF] September 11, 2017


Responsible Party: Eric A. Hoffman, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03382106     History of Changes
Other Study ID Numbers: 201706713
R01HL130883 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents