{"id":3157,"date":"2022-12-28T16:09:17","date_gmt":"2022-12-28T21:09:17","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/pulmonary\/?page_id=3157"},"modified":"2026-06-02T12:11:37","modified_gmt":"2026-06-02T16:11:37","slug":"unc-cf-clinical-studies","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/medicine\/pulmonary\/patient-care\/pulmonary-subspecialty-care\/cystic-fibrosis\/unc-cf-clinical-studies\/","title":{"rendered":"UNC CF Clinical Studies"},"content":{"rendered":"<p>The UNC CF Center is a leader in cystic fibrosis research, spanning basic laboratory science to patient\u2011oriented studies. The Marsico Lung Institute houses many investigators focused on the causes and treatment of CF lung and gut disease.<\/p>\n<p>Patient-oriented research is a core priority. We run single\u2011center studies that develop new tests to accelerate drug development and deepen our understanding of CF lung disease. We also participate in\u2014and often lead\u2014multi\u2011center clinical trials of emerging CF therapies. In today\u2019s rapidly advancing therapeutic landscape, teamwork is essential. Patients with CF are at the heart of this work, and we aim to involve as many as possible in studies that move promising treatments toward approval.<\/p>\n<p>Our research team includes physician\u2011investigators, expert research coordinators, and regulatory specialists. Below, you can find active studies at UNC, and you can use the\u00a0<a href=\"https:\/\/www.cff.org\/Trials\/finder\">Clinical Trials Finder<\/a>\u00a0to explore CF trials by therapeutic approach, location, and key inclusion criteria.<\/p>\n<p>If you\u2019re interested in learning more about these studies or their results, please email or call us.\u00a0<strong>YOU ARE THE KEY!<\/strong><\/p>\n<p><a href=\"mailto:CFclinicalresearch@med.unc.edu\">CFclinicalresearch@med.unc.edu<\/a><\/p>\n<p>&nbsp;<\/p>\n<h3><b>CURRENT UNC CLINICAL STUDIES<br \/>\n<\/b><\/h3>\n<p><b><span data-olk-copy-source=\"MessageBody\">STOP PEDS RCT: Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial<\/span><\/b><br \/>\n<i>The aim of the\u00a0STOP PEDS RCT\u00a0main cohort (ages 6-18 on HEMT)\u00a0is\u00a0to\u00a0assess the long-term and short-term efficacy and safety\u00a0of two approaches for the treatment of outpatient\u00a0pulmonary exacerbations in\u00a0children with CF: immediate antibiotics vs. tailored therapy.\u00a0The goal of the preschool (ages 3-5 on HEMT) and non-HEMT (ages 6-18 not on HEMT) pilot cohorts is to estimate the proportion of antibiotic use in the tailored therapy arm, gather preliminary safety and efficacy data, and evaluate feasibility of a potential larger trial.<\/i><br \/>\n<b>Population:\u00a0<\/b>Children ages\u00a03-18<br \/>\n<b>Sponsor:\u00a0<\/b>CFF<br \/>\n<b>PI:\u00a0<\/b>Dr. Jennifer Goralski<\/p>\n<p><b>Sinus Disease in Young Children with Cystic Fibrosis<br \/>\n<\/b><i>This study assesses how CF affects the sinuses and sense of smell among children under the age of 11. Participants undergo a short MRI scan, a smell test, and surveys once a year for five years.<br \/>\n<\/i><b>Population:\u00a0<\/b>Children under 11 years old<br \/>\n<b>Sponsor:\u00a0<\/b>CFF<br \/>\n<b>PI:\u00a0<\/b>Dr. Jane Gross<\/p>\n<p><b>A cross-sectional pilot study of 19F MRI in healthy children and children with mild cystic fibrosis lung disease<br \/>\n<\/b><i>This study\u00a0involves using an imaging\u00a0technique called 19F MRI, which entails breathing a contrast gas to visualize the lungs on MRI\u00a0in\u00a0pediatric populations.\u00a0Both children with CF and children without lung disease are scanned and compared, and the study hopes to assess the feasibility of 19F MRI\u00a0in pediatric participants.\u00a0Please see\u00a0<\/i><a title=\"https:\/\/youtu.be\/C-UcW9PMPEU?si=jAX_Do9C14Hqtqz5\" href=\"https:\/\/youtu.be\/C-UcW9PMPEU?si=jAX_Do9C14Hqtqz5\" target=\"_blank\" rel=\"noopener noreferrer\" data-auth=\"NotApplicable\" data-linkindex=\"0\"><i>here<\/i><\/a><i>\u00a0for a\u00a0video\u00a0demonstration of the scan.<\/i><br \/>\n<b>Population:\u00a0<\/b>Age\u00a06-17\u00a0years<br \/>\n<b>Sponsor:\u00a0<\/b>CFF<br \/>\n<b>PI:\u00a0<\/b>Dr. Jennifer Goralski<\/p>\n<p><b>Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis (POSTSTAMP)<br \/>\n<\/b><i>The primary\u00a0objective\u00a0of\u00a0<b>PREDICT<\/b>\u00a0is to implement a standardized approach to establishing a diagnosis of Nontuberculous Mycobacteria disease.<br \/>\n<\/i><i>The primary\u00a0objective\u00a0of\u00a0<b>PATIENCE<\/b>\u00a0is to implement a standardized approach to the treatment of Nontuberculous Mycobacteria (NTM) in CF patients with a diagnosis of NTM disease.<br \/>\n<\/i><i>The primary\u00a0objective\u00a0of\u00a0<b>POSTSTAMP<\/b>\u00a0is to collect data from patients whose Nontuberculous Mycobacteria (NTM) has not responded to typical NTM antibiotics. If applicable, you will be given an opportunity to consent to receive phage treatment for 12 months in addition to antibiotics that you are already receiving.<br \/>\n<\/i><b>Population:\u00a0<\/b>6+ years<br \/>\n<b>Sponsor:\u00a0<\/b>CFF<br \/>\n<b>PI:\u00a0<\/b>PREDICT\/PATIENCE: Dr. Jennifer Goralski, POSTSTAMP:\u00a0Dr.<b>\u00a0<\/b>Jane Gross<\/p>\n<p><b>REACH-OB-23: A Research Study to Advance the CF Therapeutics Pipeline for People without Modulators<br \/>\n<\/b><i>The goal of this study is to collect health information and specimens from people with CF who do not take CFTR modulators.\u00a0The hope\u00a0is\u00a0that these data may help design CF clinical studies and support the development of new treatments for people with CF who do not take CFTR modulators.<\/i><br \/>\n<b>Population:\u00a0<\/b>12+ years<br \/>\n<b>Sponsor:\u00a0<\/b>CFF<br \/>\n<b>PI:\u00a0<\/b>Dr. Scott Donaldson<\/p>\n<p><b>F19-MRI Study of CF vs. Healthy Lungs<\/b><br \/>\n<i>This study is designed to develop a technique to allow visualization of ventilation (ventilation mapping) in the lung using an inhaled MRI contrast\u00a0gas.\u00a0Healthy\u00a0participants and people with lung diseases (e.g., CF, COPD)\u00a0will be enrolled to begin to describe\u00a0lung\u00a0changes.<\/i><br \/>\n<b>Population:\u00a0<\/b>18+ years<br \/>\n<b>Sponsor:<\/b>\u202fNIH<br \/>\n<b>PI:<\/b>\u202fDr.\u00a0Jennifer Goralski<\/p>\n<p><b>SUN-CF: Screening for Unmet Needs in Cystic Fibrosis<br \/>\n<\/b><i>This study\u00a0involves the use of survey data to\u00a0assess\u00a0self-reported and caregiver-reported\u00a0social, ethical, and behavioral aspects of unmet needs in adult and pediatric CF populations.\u00a0Using this data, the\u00a0study aims to develop a\u00a0widely used screening tool for the CF community that may assess these needs.<\/i><br \/>\n<b>Population:\u00a0<\/b>18+ years; adults with CF and parents of children with CF<br \/>\n<b>Sponsor:\u00a0<\/b>CFF<br \/>\n<b>PI:<\/b>\u00a0Dr. Jennifer Goralski<\/p>\n<p><b>Health Outcomes of Parents with Cystic Fibrosis (HOPeCF)<br \/>\n<\/b><i>The purpose of this study is to\u00a0determine\u00a0the\u00a0effect first-time\u00a0parenthood may have on the health of people with CF.\u00a0This study will collect information through\u00a0questionnaires\u00a0administered over 5 years.\u00a0<\/i><b>\u00a0<\/b><br \/>\n<b>Population:\u00a0<\/b>18+ years with\u00a0CF,\u00a0becoming\u00a0a parent<br \/>\n<b>Sponsor:\u00a0<\/b>CFF<br \/>\n<b>PI:\u00a0<\/b>Dr. Elisabeth Dellon<\/p>\n<p><b>UNC RTCC Clinical Translation Core: Biopsy Bank<br \/>\n<\/b><i>The purpose of this study is to collect blood, tissue or body fluids (specimens) that can help researchers understand how the human body works, and how diseases occur. This research can lead to the development of new tests to diagnose diseases, and new ways to treat diseases.\u00a0\u00a0Specimens collected can include blood, urine, nasal tissue, sputum, sweat chloride, exhaled breath condensation, and lung tissue.<br \/>\n<\/i><b>Population:\u00a0<\/b>18+ years<br \/>\n<b>Sponsor:\u00a0<\/b>NIH<br \/>\n<b>PI:\u00a0<\/b>Dr. Scott Donaldson<\/p>\n<p><strong><u>To learn more about how CF patients at UNC have contributed to past CF research, please see our informative flyer below!<\/u><\/strong><\/p>\n<p><a href=\"https:\/\/www.med.unc.edu\/medicine\/pulmonary\/wp-content\/uploads\/sites\/1321\/2026\/06\/CF-Flyer.pdf\">CF Flyer<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The UNC CF Center is a leader in cystic fibrosis research, spanning basic laboratory science to patient\u2011oriented studies. The Marsico Lung Institute houses many investigators focused on the causes and treatment of CF lung and gut disease. Patient-oriented research is a core priority. We run single\u2011center studies that develop new tests to accelerate drug development &hellip; <a href=\"https:\/\/www.med.unc.edu\/medicine\/pulmonary\/patient-care\/pulmonary-subspecialty-care\/cystic-fibrosis\/unc-cf-clinical-studies\/\" aria-label=\"Read more about UNC CF Clinical Studies\">Read more<\/a><\/p>\n","protected":false},"author":112673,"featured_media":0,"parent":3048,"menu_order":10,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-3157","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 - Division of Pulmonary Diseases and Critical Care Medicine<\/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\/medicine\/pulmonary\/patient-care\/pulmonary-subspecialty-care\/cystic-fibrosis\/unc-cf-clinical-studies\/\" \/>\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 - Division of Pulmonary Diseases and Critical Care Medicine\" \/>\n<meta property=\"og:description\" content=\"The UNC CF Center is a leader in cystic fibrosis research, spanning basic laboratory science to patient\u2011oriented studies. 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