REACH stands for: REsearch Study to Advance the CF THerapeutics Pipeline for People without Modulators. REACH is a one-of-a-kind research study for people with cystic fibrosis (CF) who are not on modulators, regardless of the reason. The goal of REACH is to collect health information and specimens (like blood) from people who do not take modulators. REACH research participants will have four study visits over a year at a research site. Also, participants will complete at-home surveys and home spirometry monthly. The data collected in REACH will be used in multiple ways to advance science and move towards new and better treatments for people with CF. REACH is not testing a new drug, but the data we collect in the REACH study will be used to help evaluate the next generation of CF therapies and treatments.
Join REACH
People who are not on modulators make up at least 10% of people with cystic fibrosis, and they do not benefit from these recent medical advances. We need you to enroll in the REACH study for people not on modulators to help make better treatments and therapies in CF.
Participating in research is vital to develop new treatments for cystic fibrosis.
We know making time for research can be challenging. Participants will be paid for their participation based on the number of visits and procedures completed. If you don’t live near a REACH study site, we can also pay for your travel costs so you can be a part of REACH.
All participants will have the opportunity to receive a home spirometer. REACH participants may also enroll in sub-studies available at select sites including: (1) Multiple Breath Washout, (2) Mucociliary Clearance, and (3) Blood and Immune Studies. If you enroll in REACH, you may be eligible for these opportunities. More information will be available at your research site.
Are you eligible for REACH?
You Must Meet All Three Criteria to Join the Study
What is Cystic Fibrosis (CF)?
Cystic fibrosis is a genetic condition that affects about 40,000 people in the United States. When the cystic fibrosis transmembrane conductance regulator (CFTR) gene has mutations, the body doesn’t make a working CFTR protein or enough of it. A lack of this protein causes an imbalance of salt and fluids inside and outside of the cells of people with cystic fibrosis causing people with cystic fibrosis to have thick and sticky mucus that gets stuck in their lungs, pancreas, and other organs. There are thousands of CFTR genetic mutations but not all of them respond to CFTR modulator drugs. To learn more about cystic fibrosis, please visit the CF Foundation website here >>
Learn More about CFTR Modulators.
CFTR modulators are a recent class of drugs that improve CFTR protein. Examples of CFTR modulators include Kalydeco®, Trikafta®, and Alyftrek ®. These drugs have helped many people with cystic fibrosis live longer, and healthier lives, but not all people with CF can take modulators. It is estimated that at least about 4,000-6,000 people with cystic fibrosis in the United States are unable to take modulators for reasons that may include:
• Certain cystic fibrosis mutations do not respond to modulator treatments
• The side effects may be too much to handle
• Some people choose not to take medications for personal reasons
REACH is a study for people not on modulators. Learn how REACH is unique.
REACH is an observational study, which means it does not include testing a drug or device. In REACH, we specifically want to engage people with cystic fibrosis who do not take modulators in research. We aim to collect data on your health, just as it is. Importantly, this data can help develop new drugs and trials for people with CF.
Am I eligible to enroll in REACH?
To enroll in REACH, you need to be (1) a person with cystic fibrosis who is (2) not on modulators and (3) is at least 12 years old. To enroll, contact the Cystic Fibrosis Foundation (CFF) Trial Navigator at TrialNavigator@cff.org or ask the research coordinator or care team at your CF Center.
How do I enroll in REACH?
To enroll, contact the CFF Trial Navigator at TrialNavigator@cff.org or ask the research coordinator or care team at your CF Center.
How long is the REACH study?
Participation lasts one year. You will have research site visits at baseline and 3, 6 and 12 months later. You will also collect some information, like spirometry and surveys, monthly at home.
Tell me about the data that will be collected as part of the REACH study.
When you enroll in REACH, you commit to 4 research-site visits and 12 monthly in-home data collections. The research-site visits are mostly similar to a clinical care visit. We will collect information like vital signs, lung function, questionnaires, medical history and blood specimens. The in-home data collections include lung function testing and surveys.
Will travel expenses be covered?
Yes! If you need to travel to a research site, the Research Coordinator will connect you with a travel agency to arrange and pay for travel costs.
Do I get paid for enrolling in REACH?
Participants will be paid for their participation with the amount varying based on the number of visits and procedures completed. If you don’t live near an approved research site, we will also pay for your travel costs so you can be a part of REACH. More information will be available at your research site.
How you receive compensation will depend on the research site. At most of the REACH sites, you will receive your compensation on a debit card. REACH Research ccompensation may be taxable. Research sites are required to report to the IRS payments totaling $600 or more made to anyone in any one per year to the IRS.
Can I leave the study?
Yes. Research participation is always optional, and participants can leave this study at any time.
Who is leading the REACH study?
REACH funding is provided by the Cystic Fibrosis Foundation and administered by the Cystic Fibrosis Therapeutic Development Network. The Principal Investigator is Dr. Deepika Polineni at Washington University school of Medicine in St. Louis. She is working with a team of physicians and scientists. Click here to learn more about our research team >>
REACH is also guided by our advisory boards: a Community Advisory Board and Social Engagement Advisory Board of people with cystic fibrosis who are not on modulators and an Expert Advisory Board of doctors who care for people with cystic fibrosis. Click here to meet the REACH Community Leaders >>
How will the REACH data be used and stored?
Data from REACH will be de-identified, meaning names, addresses, dates of birth and other identifying details will be removed from the final file. Data and specimens will be securely stored at the Cystic Fibrosis Therapeutic Development Network Coordinating Center and in the Cystic Fibrosis Foundation Biorepository. REACH data may be shared with researchers, and with regulators, and may be used for commercial purposes with companies developing treatments for cystic fibrosis.
