A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators
NCT ID: NCT06504589
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-09-18
2029-08-14
Brief Summary
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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.
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Detailed Description
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The REACH Study is a prospective, longitudinal, observational research study to obtain research quality (i.e., monitored research) CF outcome data. Primary outcome endpoints of the Core study (collected across all study participants) are aligned with anticipated clinical trial outcome endpoints needed in overall development of therapies for the CF population unable to benefit from CFTR modulators. This study will also include sub-studies to obtain specialized measures which may help inform efficacy and safety evaluations of new therapies by providing CF control data. Finally, this study also seeks to assess research solicitation and research participation for the CF population that is modulator ineligible or not taking modulators. The observational data collected within this study may be used in characterizing this CF population, developing innovative trial designs, for comparison when evaluating new or experimental CF therapies, and/or in CF research.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
C. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and/or behavioral intervention trials is allowed.
D. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1
E. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1
12 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Florida State University
OTHER
University of North Carolina, Chapel Hill
OTHER
University of Toronto
OTHER
Cystic Fibrosis Foundation
OTHER
Nicole Hamblett
OTHER
Responsible Party
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Nicole Hamblett
Professor of Pediatrics, Division of Pulmonary and Sleep Medicine, UW School of Medicine Adjunct Professor, Biostatistics, UW School of Medicine Co-Executive Director, CF Therapeutics Development Network
Principal Investigators
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Deepika Polineni, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Nicole Mayer-Hamblett, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Scott Donaldson, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Felix Ratjen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Tucson Cystic Fibrosis Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego
La Jolla, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
University of California, San Francisco - Adult Center
San Francisco, California, United States
University of California, San Francisco - Peds Center
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Tulane University
Metairie, Louisiana, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States
Wayne State University Harper University Hospital
Detroit, Michigan, United States
Corewell Health Helen DeVos
Grand Rapids, Michigan, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Morristown Medical Center
Morristown, New Jersey, United States
The Cystic Fibrosis Center of Western New York
Buffalo, New York, United States
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Columbia University Cystic Fibrosis Program
New York, New York, United States
University of Rochester Medical Center Strong Memorial
Rochester, New York, United States
New York Medical College at Westchester Medical Center
Valhalla, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Cystic Fibrosis Program
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Children's Hospital - Midlands
Columbia, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
University of Texas Southwestern / Children's Health
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Adult Cystic Fibrosis Center at the University of Utah
Salt Lake City, Utah, United States
Inova L.J. Murphy Pediatric CF Program
Fairfax, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Providence Medical Group, Cystic Fibrosis Clinic
Spokane, Washington, United States
West Virginia University - Morgantown
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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REACH-OB-23
Identifier Type: -
Identifier Source: org_study_id
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