Clinical trial NCT03382106: Smoking Cessation and Functional CT Assessment
Official title: Smoking Cessation and Functional CT Assessment of Pulmonary Arterial Dysfunction in Smoking Associated Emphysema
Conditions: Emphysema
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.
Interventions:
description: Sildenafil, 20mg three times daily for 3 month period.
name: Sildenafil 20 MG
other_name: Experimental: Non-Smokers Group 1
Experimental: Smoking Cessation Group 1
type: Drug
description: Placebo manufactured to look like Sildenafil 20 MG
name: Placebo Oral Tablet
other_name: No Intervention: Smoking Cessation Group 2
type: Drug
description: Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.
name: Pulse wave velocity
type: Diagnostic Test
description: An echocardiogram is done by using a probe placed on the skin.
name: Carotid artery compliance and stiffness
type: Diagnostic Test
description: Carotid pulse measurement taken using a tonometer probe
name: Pressure wave reflection
type: Diagnostic Test
Study arms:
design_group_description: 80 normal smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews), between the ages of 21 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. Pulse wave velocity, carotid artery compliance and stiffness and pressure wave reflection will be measured.
design_group_title: Smoking Cessation Group 1
design_group_type: Experimental
design_group_description: 80 normal smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews), between the ages of 21 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. Pulse wave velocity, carotid artery compliance and stiffness and pressure wave reflection will be measured.
design_group_title: Smoking Cessation Group 2
design_group_type: Placebo Comparator
design_group_description: 20 non-smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews) between the ages of 21 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.
design_group_title: Non-Smokers Group 1
design_group_type: Experimental
design_group_description: 20 non-smokers will be recruited (defined by Pulmonary Function Tests, questionnaires and interviews) between the ages of 21 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.
design_group_title: Non-Smokers Group 2
design_group_type: No Intervention
Sponsor: University of Iowa
Collaborators: National Heart, Lung & Blood Institute
National Institutes of Health
Drug name mappings:
name: 枸橼酸西地那非
lang: CN
name: Sildenaifl Citrate
lang: EN
name: シルデナフィルクエン酸塩
lang: JP