{"id":384,"date":"2017-01-06T15:15:00","date_gmt":"2017-01-06T20:15:00","guid":{"rendered":"https:\/\/med.sites.unc.edu\/cfpulmcenter\/adult-cf-program\/clinical-trials\/"},"modified":"2026-02-20T15:46:59","modified_gmt":"2026-02-20T20:46:59","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/marsicolunginstitute\/adult-cf-program\/clinical-trials\/","title":{"rendered":"UNC CF Clinical Studies"},"content":{"rendered":"<p><!-- portlet_header --><\/p>\n<p><!-- portlet_above --><\/p>\n<p><!-- description --><\/p>\n<p class=\" \">The UNC CF Center is a recognized leader in the science of CF, with activities that span from basic laboratory to patient oriented research. The Marsico Lung Institute is the academic home for a large number of researchers who are focused on the basic causes and treatment of CF lung and gut disease. More can be learned by visiting our website.<\/p>\n<p>Patient-oriented research is also a high priority at the UNC CF Center. We conduct single center studies that address important topics, such as the development of new tests that are designed to speed up drug development and help us learn more about CF lung disease in patients. We also participate, and often lead, multi center clinical trials of new CF therapies. In this era of rapidly advancing CF therapeutics, teamwork is critical. Patient with CF are the center of this team \u2013 and we strive to involve as many patients as possible in studies that will move new therapies closer to approval for all CF patients. Our team also includes physician investigators, highly skilled research coordinators and regulatory specialists. You can learn more about studies being conducted at UNC below, and can use the Clinical Trial Finder to search all CF clinics trials by therapeutic approach, location, and inclusion criteria (including age, lung function and genotype).<\/p>\n<p>Give us a call if you are interested in participating in any of the research studies you find on these sites! YOU ARE THE KEY!<\/p>\n<h2><b><span style=\"text-decoration: underline\">UNC CLINICAL STUDIES<\/span><br \/>\n<\/b><\/h2>\n<p><span style=\"text-decoration: underline\"><b>INVESTIGATOR INITIATED STUDIES:<\/b><\/span><\/p>\n<p><strong>Xenon vs F19-MRI<br \/>\n<\/strong><em>This study is designed to compare the capabilities of two novel imaging techniques: polarized perfluorinated gas mixed with oxygen, and hyperpolarized xenon mixed with N2 to detect changes in lung ventilation using MRI.<br \/>\n<\/em><strong>Sponsor:<\/strong> NIH<br \/>\n<strong>PI:<\/strong> Dr. Jennifer Goralski<br \/>\n<strong>Lead Research Coordinator:<\/strong> Margret Powell<br \/>\n<strong>Contact Info:<\/strong> <a href=\"mailto:Kelsey_haywood@med.unc.edu\">margret_powell@med.unc.edu <\/a><br \/>\n<strong>Enrollment:<\/strong> Closed<\/p>\n<p><strong>F19-MRI Study of CF vs. Healthy Lungs<br \/>\n<\/strong><em>This study is designed to develop a technique to allow visualization of ventilation (ventilation mapping) in the lung using inhaled perfluorpropane as an inhaled MRI contrast agent. Healthy and CF subjects will be enrolled to begin to describe CF specific changes<br \/>\n<\/em><strong>Sponsor:<\/strong> NIH<br \/>\n<strong>PI:<\/strong> Dr. Jennifer Goralski<br \/>\n<strong>Lead Research Coordinator:<\/strong> Margret Powell<br \/>\n<strong>Contact Info:<\/strong> <a href=\"mailto:Kelsey_haywood@med.unc.edu\">margret_powell@med.unc.edu\u00a0<\/a><br \/>\n<strong>Inclusion Criteria:<\/strong><\/p>\n<ul>\n<li>Male or Female \u00b3 18 years of age.<\/li>\n<li>Healthy volunteers and CF adults with FEV1 &gt;30% of predicted.<\/li>\n<li>Time Commitment: 1-3 Visits over 1-15 days.<\/li>\n<\/ul>\n<p><strong>F19-MRI Study: Effect of CF Exacerbation Treatment<br \/>\n<\/strong><em>This study will use F19-MRI to visualize ventilation in CF patients experiencing a pulmonary exacerbation, and again following treatment for that exacerbation.\u00a0 Correlation to traditional markers of lung disease (e.g. spirometry) will be made.<br \/>\n<\/em>Sponsor: NIH<br \/>\n<strong>PI:<\/strong> Dr. Jennifer Goralski<br \/>\n<strong>Lead Research Coordinator:<\/strong> Margret Powell<br \/>\n<strong>Contact Info:<\/strong> <a href=\"mailto:Kelsey_haywood@med.unc.edu\">margret_powell@med.unc.edu <\/a><br \/>\n<strong>Inclusion Criteria:<\/strong><br \/>\n&#8211; Male or Female \u00b3 18 years of age.<br \/>\n&#8211; CF patients experiencing a pulmonary exacerbation.<br \/>\n&#8211; FEV1 <u>&gt;<\/u>30% predicted.<br \/>\n&#8211; Time Commitment: 1-3 visits for a total of 7 hours over a 3 week period.<\/p>\n<p><span style=\"text-decoration: underline\"><b>MULTICENTER CLINICAL TRIALS:<\/b><\/span><\/p>\n<p><b>Treatment of Pulmonary Exacerbations in people with CF (STOP 2)<\/b><i><br \/>\nThis study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of different lengths of IV treatment for pulmonary exacerbations in people with CF.<\/i><b><br \/>\nSponsor<\/b>: CFF<br \/>\n<strong>PI:<\/strong> Dr. Jennifer Goralski<br \/>\n<strong>Enrollment:<\/strong> Closed<\/p>\n<p><strong>A Phase 1 Study to Evaluate the Saftey, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis<br \/>\n<\/strong><em>This study is taking place at multiple care centers across the U.S. It will evaluate the safety, tolerability, and pharmacokinetics of PTI-808 in Healthy Volunteers and Adults in with Cystic Fibrosis.<br \/>\n<\/em><strong>Sponsor: <\/strong>Proteostasis Therapeutics, Inc.<br \/>\n<strong>PI: <\/strong>Dr. Scott Donaldson<br \/>\n<strong>Lead Research Coordinator: <\/strong>JD Harris<br \/>\n<strong>Contact Info: <\/strong><a href=\"mailto:jd_harris@med.unc.edu\">jd_harris@med.unc.edu<\/a><br \/>\n<b>Enrollment: <\/b>Closed<\/p>\n<p><strong>VX17-445-105: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation<br \/>\n<\/strong><em>This study is taking place at multiple care centers across the U.S. It will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with Cystic Fibrosis (CF) who are homozygous or heterozygous for the F508del mutation. <\/em><br \/>\n<strong>Sponsor<\/strong>: Vertex Pharmaceuticals Incorporated<br \/>\n<strong>PI:<\/strong> Dr. Scott Donaldson<br \/>\n<strong>Lead Research Coordinator:<\/strong> Alex Nesbit<br \/>\n<strong>Contact Info:<\/strong> <a href=\"mailto:alexandria_nesbit@med.unc.edu\">alexandria_nesbit@med.unc.edu\u00a0<\/a><br \/>\n<strong>Enrollment:<\/strong> Closed \u00a0<strong>\u00a0<\/strong><\/p>\n<p><strong>TEACH: Testing the effect of adding oral azithromycin to inhaled tobramycin in people with CF (TEACH-IP-15)<br \/>\n<\/strong><em>This study is taking place at multiple care centers acr<\/em><em>oss the U.S. <\/em><em>It is for people with CF who are chronically infected with P. aeruginosa and are taking inhaled tobramycin.<br \/>\n<\/em><strong>Sponsor<\/strong>: CFF<br \/>\n<strong>PI:<\/strong> Dr. George Retsch-Bogart<br \/>\n<strong>Lead Research Coordinator:<\/strong> JD Harris<br \/>\n<strong>Contact Info:<\/strong> <a href=\"mailto:jd_harris@med.unc.edu\">jd_harris@med.unc.edu<\/a><br \/>\n<b>Enrollment: <\/b>Closed<\/p>\n<p><strong>Early MRSA Therapy in CF (Streamlined Eradication with Repeat Cycle) (Staph Aureus Resistance \u2013 Treat Early and Repeat (STAR-ter))<br \/>\n<\/strong><em>This is an open-label clinical trial being conducted at numerous CF care centers across the US. It will investigate the microbiological efficacy and safety of a streamlined two-week MRSA eradication treatment protocol.<br \/>\n<\/em><strong>Sponsor:\u00a0<\/strong>CFF<br \/>\nPI: Dr. Marianne Muhlebach<br \/>\nLead Research Coordinator: Fiona Cunningham<br \/>\nContact Info: <a href=\"mailto:fiona_cunningham@med.unc.edu\">fiona_cunningham@med.unc.edu<\/a><br \/>\nInclusion criteria:<br \/>\n-Male or female \u2265 2 and \u2264 45 years of age<br \/>\n-First or Early MRSA colonization:<br \/>\n&#8211; First = First life-time isolation of MRSA<br \/>\n&#8211; Early = MRSA isolated \u2264 2 times over the past 3.5 years<br \/>\n-Time Commitment: 4 Visits over a 6-month time period.<\/p>\n<p>To search for additional Clinical Trials that you may be eligible for please go to the <span class=\"external-link\">Cystic Fibrosis Foundation&#8217;s<\/span><a class=\"external-link\" title=\"CFF Clinical Trials Finder \" href=\"https:\/\/www.cff.org\/Trials\/finder\" target=\"_self\" rel=\"noopener noreferrer\"> Clinical Trials Finder.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The UNC CF Center is a recognized leader in the science of CF, with activities that span from basic laboratory to patient oriented research. The Marsico Lung Institute is the academic home for a large number of researchers who are focused on the basic causes and treatment of CF lung and gut disease. More can &hellip; <a href=\"https:\/\/www.med.unc.edu\/marsicolunginstitute\/adult-cf-program\/clinical-trials\/\" aria-label=\"Read more about UNC CF Clinical Studies\">Read more<\/a><\/p>\n","protected":false},"author":76119,"featured_media":0,"parent":11,"menu_order":9,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-384","page","type-page","status-publish","hentry","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>UNC CF Clinical Studies | Marsico Lung Institute<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/marsicolunginstitute\/adult-cf-program\/clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UNC CF Clinical Studies | Marsico Lung Institute\" \/>\n<meta property=\"og:description\" content=\"The UNC CF Center is a recognized leader in the science of CF, with activities that span from basic laboratory to patient oriented research. The Marsico Lung Institute is the academic home for a large number of researchers who are focused on the basic causes and treatment of CF lung and gut disease. 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