A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
NCT Number: NCT06504589
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cystic Fibrosis
Sponsor: Nicole Hamblett
Collaborators: Washington University School of Medicine|Florida State University|University of North Carolina, Chapel Hill|University of Toronto|Cystic Fibrosis Foundation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2029-08-14
Locations: The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States|Phoenix Children's Hospital, Phoenix, Arizona, 85016, United States|Tucson Cystic Fibrosis Center, Tucson, Arizona, 85724, United States|University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|University of California San Diego, La Jolla, California, 92093, United States|Childrens Hospital Los Angeles, Los Angeles, California, 90027, United States|Stanford University Medical Center, Palo Alto, California, 94304, United States|University of California, San Francisco - Adult Center, San Francisco, California, 94143, United States|University of California, San Francisco - Peds Center, San Francisco, California, 94158, United States|Children's Hospital Colorado, Aurora, Colorado, 80045, United States|National Jewish Health, Denver, Colorado, 80206, United States|University of Florida, Gainesville, Florida, 32610, United States|University of Miami, Miami, Florida, 33136, United States|Central Florida Pulmonary Group, Orlando, Florida, 32803, United States|Tampa General Hospital, Tampa, Florida, 33606, United States|Children's Healthcare of Atlanta and Emory University, Atlanta, Georgia, 30322, United States|Augusta University, Augusta, Georgia, 30912, United States|Saint Luke's Cystic Fibrosis Center of Idaho, Boise, Idaho, 83702, United States|Northwestern University, Chicago, Illinois, 60611, United States|Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|University of Kentucky, Lexington, Kentucky, 40506, United States|Tulane University, Metairie, Louisiana, 70001, United States|John Hopkins Hospital, Baltimore, Maryland, 21287, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Boston Children's Hospital, Boston, Massachusetts, 02115, United States|University of Massachusetts Memorial Health Care, Worcester, Massachusetts, 01655, United States|University of Michigan, Michigan Medicine, Ann Arbor, Michigan, 48109, United States|Wayne State University Harper University Hospital, Detroit, Michigan, 48201, United States|Corewell Health Helen DeVos, Grand Rapids, Michigan, 49503, United States|The Minnesota Cystic Fibrosis Center, Minneapolis, Minnesota, 55455, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Billings Clinic, Billings, Montana, 59101, United States|University of Nebraska Medical Center, Omaha, Nebraska, 69198, United States|Morristown Medical Center, Morristown, New Jersey, 07960, United States|The Cystic Fibrosis Center of Western New York, Buffalo, New York, 14203, United States|Cohen Children's Medical Center of New York, Lake Success, New York, 11042, United States|Columbia University Cystic Fibrosis Program, New York, New York, 10032, United States|University of Rochester Medical Center Strong Memorial, Rochester, New York, 14642, United States|New York Medical College at Westchester Medical Center, Valhalla, New York, 10595, United States|University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States|Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, 27157, United States|University of Cincinnati Medical Center, Cincinnati, Ohio, 45267, United States|Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States|Cleveland Clinic Cystic Fibrosis Program, Cleveland, Ohio, 44195, United States|Nationwide Children's Hospital, Columbus, Ohio, 43205, United States|Dayton Children's Hospital, Dayton, Ohio, 45404, United States|Oregon Health & Sciences University, Portland, Oregon, 97239, United States|Hershey Medical Center Pennsylvania State University, Hershey, Pennsylvania, 17033, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15224, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Prisma Health Children's Hospital - Midlands, Columbia, South Carolina, 29203, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Dell Children's Medical Center of Central Texas, Austin, Texas, 78723, United States|University of Texas Southwestern / Children's Health, Dallas, Texas, 75207, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States|Cook Children's Medical Center, Fort Worth, Texas, 76104, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, Utah, 84132, United States|Inova L.J. Murphy Pediatric CF Program, Fairfax, Virginia, 22031, United States|Virginia Commonwealth University, Richmond, Virginia, 23219, United States|Seattle Children's Hospital, Seattle, Washington, 98105, United States|University of Washington Medical Center, Seattle, Washington, 98195, United States|Providence Medical Group, Cystic Fibrosis Clinic, Spokane, Washington, 99204, United States|West Virginia University - Morgantown, Morgantown, West Virginia, 26507, United States|University of Wisconsin, Madison, Wisconsin, 53792, United States

Summary:
The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators.

Another goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study.

Primary Outcome Measures: Change in ppFEV1 at 12 months, Mean change (standard deviation) in percent predicted forced expiratory volume in 1 second (ppFEV1) as measured by in-clinic spirometry from baseline to 12 months post-baseline., 12 months
Secondary Outcome Measures: Change in CFQ-R-RD at 12 months, Mean change (standard deviation) in the Cystic Fibrosis Question - Revised Respiratory Domain (CFQ-R-RD) from Baseline to 12 months post-baseline. Scores for the CFQ-R-RD range from 0 to 100., 12 months|Change in home spirometry ppFEV1 at 12 months, Mean change (standard deviation) in percent predicted forced expiratory volume in 1 second (ppFEV1) as measured by home spirometry from baseline to 12 months post-baseline., 12 months|Change in LCI 2.5% at 12 months, Mean change (standard deviation) in lung clearance index (LCI) calculated as 1/40th of starting end-tidal concentration of N2 (LCI 2.5%) as measured by multiple breath washout (MBW) from baseline to 12 months post-baseline., 12 months|Change in LCI 5% at 12 months, Mean change (standard deviation) in lung clearance index (LCI) calculated as 1/20th of starting end-tidal concentration of N2 (LCI 5%) as measured by multiple breath washout (MBW) from baseline to 12 months post-baseline., 12 months|Absolute 12-month change in MCC Index, Mean change (standard deviation) in mucociliary clearance (MCC) index as by the MCC procedure per gamma scintigraphy from baseline to 12 months post-baseline., 12 months|Relative 12-month change in MCC Index, Mean change (standard deviation) in mucociliary clearance (MCC) index as by the MCC procedure per gamma scintigraphy from baseline to 12 months post-baseline divided by the baseline MCC index., 12 months