Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smoking Cessation and Functional CT Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382106
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : September 12, 2019
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 the 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 the 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. Non-smokers will be enrolled to compare lung imaging and the effects of Sildenafil on their lungs with that of smokers undergoing a smoking cessation program with placebo or Sildenafil. Non-smokers will complete identifical measurements as smokers, with Sildenafil used three times per day or no medication across a similar 90 day period of time.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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. For the non-smoker groups, both subjects and the study team will know which group they are assigned to (study drug or no medication).
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 Names:
  • Experimental: Smoking Cessation Group 1
  • Experimental: Non-Smokerss 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

Experimental: Non-Smokers Group 1
20 non-smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews) between the ages of 25 and 65 will be studied to compare the heterogeneity of Perfused Blood Volume with that of smokers for a 3 month period of time. We will provide 10 females and 10 males three times per day Sildenafil 20 milligrams (MG) (Viagra) for the full 3 months.
Drug: Sildenafil 20 MG
Sildenafil, 20mg three times daily for 3 month period.
Other Names:
  • Experimental: Smoking Cessation Group 1
  • Experimental: Non-Smokerss Group 1

No Intervention: Non-Smokers Group 2
20 non-smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews) between the ages of 25 and 65 will be studied to compare the heterogeneity of Perfused Blood Volume with that of smokers for a 3 month period of time. 10 females and 10 males will not receive any medication for the full 3 months.



Primary Outcome Measures :
  1. Measure and compare individual smokers' responses to smoking cessation, Sildenafil and placebo with lung imaging to determine decrease of inflammation and increase of blood flow in lungs. [ Time Frame: 90 Days ]
    Our outcome measure is the change in regional blood volume between baseline and interventions with CT imaging, sildenafil/placebo and smoking cessation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
Layout table for location contacts
Contact: Sue E Salisbury, BS 319-356-1810 sue-salisbury@uiowa.edu
Contact: Maren Rogers 319-353-6213 maren-rogers@uiowa.edu

Locations
Layout table for location information
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
Layout table for investigator information
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


Layout table for additonal information
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: September 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: CT images will be shared including non-contrast images at TLC, FRC and RV as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be made available starting 6 months after publication of the primary results of each aim.
Access Criteria: Data will be provided to academic-based researchers upon written request to the PI, Eric A. Hoffman, PhD. A nominal charge will be made for the time it takes for a technician to prepare and transfer the requested data. These costs will not exceed $250. This service will be available for a minimum of 2 years of study close.

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