Cystic Fibrosis (CF) Research Studies
The following studies are in progress at the University of Wisconsin Cystic Fibrosis Center in Madison, Wisconsin:
FIRST Study: Feeding Infants Right from the Start
- Inclusion criteria: Diagnosed with CF by newborn screening
- Purpose of the study: The purpose of the research is to understand how different types of infant feedings, breast milk and/or infant formula, affect growth and lung health in infants with cystic fibrosis (CF). This study concludes on the child’s second birthday.
FIRST Study: Feeding Infants Right from the Start- Phase 2
- Inclusion criteria: Infants who participated in the 0-2 years FIRST study.
- Purpose of the study: The purpose of the research is to understand how infant feeding and childhood food intake influences growth and lung health in children with CF over 2-6 years of age.
A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors
- Inclusion criteria: Patients suspected of having fibrosing colonopathy (FC)
- Purpose of the study: The U.S. Food and Drug Administration (FDA) has asked the manufacturers of pancreatic enzyme supplements to study the incidence of FC in Cystic Fibrosis patients to see if there may be a link between taking pancreatic enzyme medications and developing FC.
MRI of Cystic Fibrosis Lung Disease Severity
- Inclusion criteria: Age ≥ 10 years of age
- Purpose of the study: The purpose of this study is to determine the ability of MRI to evaluate CF disease severity compared with the existing standards of breathing tests, chest x-ray, chest CT, and quality of life questionnaire.
The EPIC Observational Study: Longitudinal Assessment of Risk Factors For and Impact of Pseudomonas aeruginosa Acquisition and Early Anti-Pseudomonal Treatment in Children with CF
- Inclusion criteria: Previous participation in the EPIC observational study for years 6-10.
- Purpose of the study: The purpose of this study is to answer questions about Pseudomonas aeruginosa (Pa) and other germs that cause lung infections in people who have CF.
INSTANT (Innovative Sweat Test, A New Technology): A Multicenter Trial of A New Method of Sweat Testing
- Inclusion criteria: A diagnosis of CF or CRMS (CFTR-related metabolic syndrome)
- Purpose of the study: The primary objective is to evaluate the diagnostic accuracy of the CF Quantum Sweat Test.
The effects of viral infections and antibiotics on the microbiome in CF
- Inclusion criteria: infants with CF who are less than 4 months of age
- Purpose of the study: The purpose of the research is to understand how viral infections and antibiotics affect the bacteria that reside in the upper airway and stool of children with CF, and if these effects are related to early CF lung disease.
ARRIVAL: A Phase 3 Study of Ivacaftor in Subjects less than 24 months with a CFTR Gating mutation.
- Inclusion criteria: Diagnosis of CF with a CFTR gating mutation, Age less than 24 months
- Purpose of the study: To evaluate the safety and tolerability of ivacaftor in subjects with CF who are <24 months of age at the time of treatment initiation and have a CFTR gating mutation on at least 1 allele
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
- Inclusion criteria: Age >17 year; two copies of F508 mutation or F508 and a minimal function mutation.
- Purpose of study: to evaluate the safety and tolerability of VX-152 in Triple Combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del)
A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation (VX809-110)
- Inclusion criteria: Age >6years, homozygous for F508del and participated in the VX809-109 study
- Purpose of the study: to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor
Standardized Treatment of Pulmonary Exacerbations II (STOP2)
- Inclusion criteria: >Age >17 years and plan to initiate IV antibiotics for a pulmonary exacerbation
- Purpose of the study: This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adult patients with CF.
If you have questions about these studies, please contact our CF research coordinators:
- Adult patients: Chiron Stevens, (608) 263-1244
- Pediatric patients: Linda Makholm, (608) 262-0340