CF 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 or variants, that cause CF – the body doesn’t make a working CFTR protein or enough of it. A lack of the CFTR protein causes an imbalance of salt and fluids inside and outside of the cells of people with CF. These imbalances cause people with CF to have thick and sticky mucus that gets lodged in their lungs, pancreas, and other organs in the body. There are more than 1700 CFTR genetic mutations that are believed to cause CF, but not all can benefit from CFTR modulator drugs. To learn more about CF, please visit the CF Foundation website here >>

CFTR modulators are a newer class of drugs that improve CFTR protein. Examples of commonly used CFTR modulators are Kalydeco® and Trikafta®. CFTR modulators have helped many people with CF to live longer and healthier lives, but not all people with CF can take these drugs. It is estimated that about about 4,000-6,000  people  with CF in the United States are unable to take CFTR modulators for reasons that may include:

• Certain CF mutations do not respond to treatment with CFTR modulators

• The side effects for some people may be too much to handle

• Some people choose not to take medications for other reasons

Many people with CF are familiar with research studies. However, people with CF who do not take CFTR modulators are more likely to be new to research. In REACH, we want to engage people with CF and give them an opportunity to learn about what is involved in research. People who have not participated in research before may find the REACH study a good place to start. 

The REACH study team is committed to equity in science which means study participants are partners in research and are always encouraged to do what is in the best interest of themselves and their families .

Clinical research is the study of health and illness in people and there are two main types of clinical research: observational studies and clinical trials. Observational studies don’t involve testing a drug or device but instead gather information about people that can help identify new treatments or prevention strategies. Clinical trials test a drug, device, or behavioral intervention such as a diet to learn if it is effective and identify possible side effects.

People with CF who are 12 years of age and older and who do not take a CFTR modulator may be eligible to participate in REACH. Contact your CF care provider, nearest research site, or the Cystic Fibrosis Foundation (CFF) Trial Navigator TrialNavigator@cff.org for more information.

Contact your CF care provider, nearest research site , or the CFF Trial Navigator  TrialNavigator@cff.org for information on how to enroll. For people with CF who receive their care at a place that is not directly participating in REACH, they can still be referred to a participating study site. 

People who enroll in REACH will be in the study for up to one year. They will have study visits when they begin the study, and 3, 6 and 12 months later.

REACH study visits are similar to typical CF clinical care visits. Data on vital signs, lung function, medications, questionnaires, medical history and occasionally blood specimens will be collected. There will also be data collected monthly that is remote (lung function testing at home and questionnaires). Participants at some sites will have additional specialized tests focused on blood cells and measuring lung function in more detail.

You will need to talk with the research coordinator at the study site of your choice. If you decide to participate, the study site research coordinator will put you in contact with a travel agency to arrange and pre-pay for travel (including airline/train/hotel/car rentals, as needed). Parking, mileage and meals may be reimbursed after the visit, so talk to your research coordinator for details. 

The research coordinator at your study site will provide details on how much participants will be paid and the process. Participants in the REACH study are compensated for each study visit that they complete. Additionally, at some sites there are some specialized studies that require additional time to complete. Those study procedures result in additional time and compensation for participants.

How you receive compensation will depend on the study site but at most of the REACH sites you will receive your compensation via a reloadable debit card. REACH compensation may be taxable. Study sites are required to report to the IRS payments totaling $600 or more made to anyone in any one year.

In any research study, participants are always free to leave the study whenever they would like, including if they decide to participate in a drug trial. REACH participants may choose to leave the study any time. 

REACH is sponsored by the Cystic Fibrosis Foundation and guided by the CF Therapeutic Development Network. The Principal Investigator leading the study is Dr. Deepika Polineni at Washington University school of Medicine in St. Louis, working with a team of physicians and scientists. Click here to learn more about the REACH study investigators >>

REACH is also guided by a Community Advisory Board of people with CF who do not benefit from CFTR modulators and their family members, and an Expert Advisory Board of CF doctors from across the US.

Data from participants in the REACH study will be “de-identified”.  This means that the study information will not contain names, addresses, dates of birth or other identifying details. The REACH study data will be kept in a secure database that is used for storing information on rare diseases (like CF) to promote global collaboration between highly committed researchers, industry partners and regulators to help advance new therapies. REACH data are intended to be shared with CF researchers at universities, industry partners, and regulators (e.g., the U.S. Food and Drug Administration) engaged in scientific discovery and for commercial purposes with companies developing treatments for CF.

Anyone who requests access to the REACH data or banked specimens must submit an application for a review of scientific merit by the CFF and the REACH study team.  If data access is granted the applicant must also comply with all applicable data protection laws, and have Institutional Review Board (IRB) approval as applicable.  

Information that is collected in the REACH study will be de-identified. This means the study information will not include a name, address, date of birth, or other identifying details. The study data or specimens will be securely stored with REACH study investigators at the Cystic Fibrosis Therapeutic Development Network Coordinating Center  (TDNCC) and the Cystic Fibrosis Foundation Biorepository.   REACH study data are intended to be stored on a secure database. It is used for storing information on rare diseases, like CF, to promote global collaboration between highly committed researchers and regulators  to help advance new therapies. Anyone who requests access to any REACH study data, including specimens, must comply with their country’s data protections laws.

Contact your CF care provider, nearest research site,  or the Cystic Fibrosis Foundation (CFF) Trial Navigator for more information, or how to enroll. If you receive your care at a center that is not a research site for the REACH Study, you can still be referred to a participating study site.