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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
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
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 Clinical Trials Finder<\/a> to explore CF trials by therapeutic approach, location, and key inclusion criteria.<\/p>\n If you\u2019re interested in learning more about these studies or their results, please email or call us. YOU ARE THE KEY!<\/strong><\/p>\n CFclinicalresearch@med.unc.edu<\/a><\/p>\n <\/p>\n <\/p>\n Sinus Disease in Young Children with Cystic Fibrosis<\/strong> Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis (POSTSTAMP)<\/strong> F19-MRI Study of CF vs. Healthy Lungs<\/strong> A Phase 1\/2, Multicenter Study Evaluating the Safety, Tolerability, and Biodistribution of RCT2100 with Single-Ascending Doses in Healthy Participants and Multiple-Ascending Doses and Proof-of-Concept in Participants with Cystic Fibrosis<\/strong> SUN-CF: Screening for Unmet Needs in Cystic Fibrosis<\/strong> REACH-OB-23: A Research Study to Advance the CF Therapeutics Pipeline for People without Modulators<\/strong> UNC RTCC Clinical Translation Core: Biopsy Bank<\/strong> Health Outcomes of Parents with Cystic Fibrosis (HOPeCF)<\/strong> A cross-sectional pilot study of 19F MRI in healthy children and children with mild cystic fibrosis lung disease<\/strong> STOP PEDS RCT: Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial<\/strong> Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis.<\/strong> Prospective Evaluation of a Standardized Approach to Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis<\/strong> 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 CF Flyer<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"CURRENT UNC CLINICAL STUDIES<\/span>
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\nThis 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.<\/em>
\nPopulation: <\/strong>Children under 11 years old
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Jane Gross<\/p>\n
\nThis study collects 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. <\/em>
\nPopulation: <\/strong>6+ years
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Jane Gross<\/p>\n
\nThis study is designed to develop a technique to allow visualization of ventilation (ventilation mapping) in the lung using an inhaled MRI contrast gas. Healthy participants and people with lung diseases (e.g., CF, COPD) will be enrolled to begin to describe lung changes.<\/em>
\nPopulation: <\/strong>18+ years
\nSponsor:<\/strong>\u202fNIH
\nPI:<\/strong>\u202fDr. Jennifer Goralski<\/p>\n
\nA study for people with CF who are ineligible to be on any modulators.\u00a0 The study is evaluating the effects of an inhaled mRNA investigational product, RCT2100.\u00a0 There are 2 arms: 1 arm is an \u201cescalation arm\u201d with treatment duration of 4 weeks, with most visits occurring three times per week at the Clinical Research Unit.\u00a0 The \u201cexpansion arm\u201d is 12 weeks of treatment with most visits occurring at the Clinical Research Unit, three times per week.\u00a0\u00a0 Both arms have a screening visit prior to treatment and a 24-week follow-up visit.\u00a0 <\/em>
\nPopulation: <\/strong>18+ years
\nSponsor:<\/strong> ReCode Therapeutics
\nPI<\/strong>: Dr. Scott Donaldson<\/p>\n
\nThis study involves the use of survey data to assess self-reported and caregiver-reported social, ethical, and behavioral aspects of unmet needs in adult and pediatric CF populations. Using this data, the study aims to develop a widely used screening tool for the CF community that may assess these needs.<\/em>
\nPopulation: <\/strong>18+ years; adults with CF and parents of children with CF
\nSponsor: <\/strong>CFF
\nPI:<\/strong> Dr. Jennifer Goralski<\/p>\n
\nThe goal of this study is to collect health information and specimens from people with CF who do not take CFTR modulators. The hope is that 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.<\/em>
\nPopulation: <\/strong>12+ years
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Scott Donaldson<\/p>\n
\nThe 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 Specimens collected can include blood, urine, nasal tissue, sputum, sweat chloride, exhaled breath condensation, and lung tissue.<\/em>
\nPopulation: <\/strong>18+ years
\nSponsor: <\/strong>NIH
\nPI: <\/strong>Dr. Scott Donaldson<\/p>\n
\nThe purpose of this study is to determine the effect first-time parenthood may have on the health of people with CF. This study will collect information through questionnaires administered over 5 years. <\/em>\u00a0<\/strong>
\nPopulation: <\/strong>18+ years with CF, becoming a parent
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Elisabeth Dellon<\/p>\n
\nThis study involves using an imaging technique called 19F MRI, which entails breathing a contrast gas to visualize the lungs on MRI in pediatric populations. Both children with CF and children without lung disease are scanned and compared, and the study hopes to assess the feasibility of 19F MRI in pediatric participants. Please see <\/em>here<\/em><\/a> for a video demonstration of the scan.<\/em>
\nPopulation: <\/strong>Age 6-17 years
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Jennifer Goralski<\/p>\n
\nThe aim of the STOP PEDS RCT main cohort (ages 6-18 on HEMT) is to assess the long-term and short-term efficacy and safety of two approaches for the treatment of outpatient pulmonary exacerbations in children with CF: immediate antibiotics vs. tailored therapy. The 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.<\/em>
\nPopulation: <\/strong>Children ages 3-18
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Jennifer Goralski<\/p>\n
\nThe primary objective of PREDICT is to implement a standardized approach to establishing a diagnosis of Nontuberculous Mycobacteria disease.<\/em>
\nPopulation: <\/strong>Age 6+ years with CF
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Jennifer Goralski<\/p>\n
\nThe primary objective of PATIENCE is to implement a standardized approach to the treatment of Nontuberculous Mycobacteria (NTM) in CF patients with a diagnosis of NTM disease.<\/em>
\nPopulation: <\/strong>Age 6+ years with CF
\nSponsor: <\/strong>CFF
\nPI: <\/strong>Dr. Jennifer Goralski<\/p>\n