UNC CF Clinical Studies | Marsico Lung Institute

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.

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 – 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).

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!

UNC CLINICAL STUDIES

INVESTIGATOR INITIATED STUDIES:

Xenon vs F19-MRI
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.
Sponsor: NIH
PI: Dr. Jennifer Goralski
Lead Research Coordinator: Margret Powell
Contact Info: margret_powell@med.unc.edu
Enrollment: Closed

F19-MRI Study of CF vs. Healthy Lungs
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
Sponsor: NIH
PI: Dr. Jennifer Goralski
Lead Research Coordinator: Margret Powell
Contact Info: margret_powell@med.unc.edu
Inclusion Criteria:

Male or Female ³ 18 years of age.
Healthy volunteers and CF adults with FEV1 >30% of predicted.
Time Commitment: 1-3 Visits over 1-15 days.

F19-MRI Study: Effect of CF Exacerbation Treatment
This study will use F19-MRI to visualize ventilation in CF patients experiencing a pulmonary exacerbation, and again following treatment for that exacerbation. Correlation to traditional markers of lung disease (e.g. spirometry) will be made.
Sponsor: NIH
PI: Dr. Jennifer Goralski
Lead Research Coordinator: Margret Powell
Contact Info: margret_powell@med.unc.edu
Inclusion Criteria:
– Male or Female ³ 18 years of age.
– CF patients experiencing a pulmonary exacerbation.
– FEV1 >30% predicted.
– Time Commitment: 1-3 visits for a total of 7 hours over a 3 week period.

MULTICENTER CLINICAL TRIALS:

Treatment of Pulmonary Exacerbations in people with CF (STOP 2)
This 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.
Sponsor: CFF
PI: Dr. Jennifer Goralski
Enrollment: Closed

A Phase 1 Study to Evaluate the Saftey, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis
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.
Sponsor: Proteostasis Therapeutics, Inc.
PI: Dr. Scott Donaldson
Lead Research Coordinator: JD Harris
Contact Info: jd_harris@med.unc.edu
Enrollment: Closed

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
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.
Sponsor: Vertex Pharmaceuticals Incorporated
PI: Dr. Scott Donaldson
Lead Research Coordinator: Alex Nesbit
Contact Info: alexandria_nesbit@med.unc.edu
Enrollment: Closed

TEACH: Testing the effect of adding oral azithromycin to inhaled tobramycin in people with CF (TEACH-IP-15)
This study is taking place at multiple care centers across the U.S. It is for people with CF who are chronically infected with P. aeruginosa and are taking inhaled tobramycin.
Sponsor: CFF
PI: Dr. George Retsch-Bogart
Lead Research Coordinator: JD Harris
Contact Info: jd_harris@med.unc.edu
Enrollment: Closed

Early MRSA Therapy in CF (Streamlined Eradication with Repeat Cycle) (Staph Aureus Resistance – Treat Early and Repeat (STAR-ter))
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.
Sponsor: CFF
PI: Dr. Marianne Muhlebach
Lead Research Coordinator: Fiona Cunningham
Contact Info: fiona_cunningham@med.unc.edu
Inclusion criteria:
-Male or female ≥ 2 and ≤ 45 years of age
-First or Early MRSA colonization:
– First = First life-time isolation of MRSA
– Early = MRSA isolated ≤ 2 times over the past 3.5 years
-Time Commitment: 4 Visits over a 6-month time period.

To search for additional Clinical Trials that you may be eligible for please go to the Cystic Fibrosis Foundation’s Clinical Trials Finder.