Recruiting

CF Therapeutics

Sponsor:

Nicole Hamblett

Code:

NCT06504589

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Cystic Fibrosis

Study ID

NCT06504589

Start date

Sep 18, 2024

Status verified date

Sep, 2025

Completion date

Aug 14, 2029

Anticipated

Primary completion date

Aug 14, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Consent

A. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian

B. Is willing and able to adhere to the study visit schedule and other protocol requirements

Demographics

A. ≥ 12 years of age at Visit 1

Medical History

A. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period

Disease History

A. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

  • Sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
  • Two well-characterized disease-causing pathogenic variants in the CFTR gene

or

  • One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol/liter with permission of the study sponsor-investigators

B. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1

C. Does not have a history of lung transplantation

Concomitant Medications

A. Not genetically eligible for a CFTR modulator according to product label indications and/or No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period

B. No use of an investigational drug within 90 days prior to and including Visit 1

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in ppFEV1 at 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Olena Boyarska

206-884-1681olena.boyarska@seattlechildrens.org

Anna Mead

206-884-7531anna.mead@seattlechildrens.org

Locations

The Children's Hospital Alabama, University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Kathryn Monroe

205-638-5599kathrynmonroe@uabmc.edu

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Natalia Argel

602-933-0343Nargel@phoenixchildrens.com

Tucson Cystic Fibrosis Center

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Elizabeth Ryan

520-850-8688elizabethryan@email.arizona.edu

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Kathleen Hicks

501-686-5527HicksKathleenT@uams.edu

Childrens Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Carmen Reyes

323-361-2662mareyes@chla.usc.edu

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Jacquelyn Spano

650-721-1132jmzirbes@stanford.edu

University of California, San Francisco - Adult Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Courtney Moreno

415-476-2984Courtney.Moreno@ucsf.edu

University of California, San Francisco - Peds Center

Recruiting

San Francisco, California, United States, 94158

Contacts

Ngoc Ly

415-476-4979Ngoc.Ly@ucsf.edu

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mary Cross

720-777-4645mary.cross@childrenscolorado.org

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Alix Wilson

303-270-2517wilsona@njhealth.org

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Chrystal Bailey

Cbailey1@peds.ufl.edu

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Ylber (Ivan) Whitaker

305-243-5545yiw2@miami.edu

Central Florida Pulmonary Group

Recruiting

Orlando, Florida, United States, 32803

Contacts

Desiree Serr

407-841-1100dserr@cfpulmonary.com

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Andrew Marino

813-844-4907armarino@usf.edu

Children's Healthcare of Atlanta and Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Ashleigh Streby

404-727-0305ashleigh.streby@emory.edu

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Heidi Stapp

706-721-7699hstapp@augusta.edu

Saint Luke's Cystic Fibrosis Center of Idaho

Recruiting

Boise, Idaho, United States, 83702

Contacts

Lejla Godusevic

208-381-4717godusevl@slhs.org

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Rachel Nelson

312-695-0415rachel.nelson@northwestern.edu

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lisa Bendy

317-278-7152lbendy@iupui.edu

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Lawrence Scott

913-588-4020lscott2@kumc.edu

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Chase Whitaker

chase.whitaker@uky.edu

859-218-4810

Tulane University

Recruiting

Metairie, Louisiana, United States, 70001

Contacts

Adrienne Savant

504-896-9436asavant1@tulane.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Margot Hardcastle

617-726-3719mhardcastle@mgh.harvard.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Robert Fowler

6173551834Robert.fowler@childrens.harvard.edu

University of Massachusetts Memorial Health Care

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Jaclyn Longtine

508-856-5472Jaclyn.Longtine@umassmed.edu

University of Michigan, Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Dawn Kruse

734-615-3266dmkruse@med.umich.edu

Wayne State University Harper University Hospital

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Debra Driscoll

313-745-2221ddriscol@med.wayne.edu

Corewell Health Helen DeVos

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Alicia Castillo Bahena

6162679304alicia.castillobahena@corewellhealth.org

The Minnesota Cystic Fibrosis Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

CF Trials Contact University of Minnesota, Participant Contact

cftrials@umn.edu

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Irma Bauer

314-747-2940irmabauer@wustl.edu

Billings Clinic

Recruiting

Billings, Montana, United States, 59101

Contacts

Jerimiah Lysinger

406-238-5137JLysinger@billingsclinic.org

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 69198

Contacts

Michel Veit

402-559-7585michel.veit@unmc.edu

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Debra Connolly

973-971-7293Debra.Connolly@atlantichealth.org

Cohen Children's Medical Center of New York

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Susan Galvin

516-321-8606sgalvin@northwell.edu

Columbia University Cystic Fibrosis Program

Recruiting

New York, New York, United States, 10032

Contacts

Emily DiMango

212-305-0290ead3@cumc.columbia.edu

University of Rochester Medical Center Strong Memorial

Recruiting

Rochester, New York, United States, 14642

Contacts

Barb Johnson

585-276-4123Barbara_Johnson@URMC.Rochester.edu

New York Medical College at Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Contacts

Zachary Messer

914-594-2352Zachary_Messer@nymc.edu

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Julie Goudy

984-974-2364julie_goudy@med.unc.edu

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Anna Pippins

apippins@wakehealth.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Kelly Thornton

513-636-0604Kelly.Thornton@cchmc.org

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Primary RC & Participant Contact General Contact

RainbowCFResearch@UHhospitals.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Diana Gilmore

614-722-4752Diana.Gilmore@nationwidechildrens.org

Dayton Children's Hospital

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Amy Jones

937-641-3693Jonesa11@childrensdayton.org

Oregon Health & Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jenna Bucher

503-494-7807bucherj@ohsu.edu

Hershey Medical Center Pennsylvania State University

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Diane M Kitch

717-531-5646dkitch@pennstatehealth.psu.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Donnelly

609-781-0307Donnellye4@email.chop.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Melissa Molter

215-662-3116melissa.molter@pennmedicine.upenn.edu

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Adrienne DeRicco

4126928069adrienne.dericco2@upmc.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ashley Warden

843-792-4349jonesash@musc.edu

Prisma Health Children's Hospital - Midlands

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Veronica Lipscomb

Veronica.Lipscomb@PrismaHealth.org

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Brijesh Patel

615-343-4865brijesh.patel@vumc.org

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

Contacts

Kristina "Tina" Adrean

512-324-9999Kadrean@ascension.org

University of Texas Southwestern / Children's Health

Recruiting

Dallas, Texas, United States, 75207

Contacts

Keianna Brown

214-456-5489Keianna.brown@utsouthwestern.edu

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Ashley Keller

214-648-6233Ashley.Keller@UTSouthwestern.edu

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Anna Reyes

682-885-6589anna.reyes@cookchildrens.org

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Tracy Mosely

832-822-3309tlmosely@texaschildrens.org

Adult Cystic Fibrosis Center at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Kristyn Packer

801-520-5106kristyn.packer@hsc.utah.edu

Inova L.J. Murphy Pediatric CF Program

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Colleen Mann

703-776-6485colleen.mann@inova.org

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Akilah Pierre-Louis

akilah.pierrelouis1@vcuhealth.org

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Sharon McNamara

206-987-3921sharon.mcnamara@seattlechildrens.org

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Lauren Bartlett

503-583-2869lrejman@uw.edu

Providence Medical Group, Cystic Fibrosis Clinic

Recruiting

Spokane, Washington, United States, 99204

Contacts

Joan Milton

509-474-4323joan.milton@providence.org

West Virginia University - Morgantown

Recruiting

Morgantown, West Virginia, United States, 26507

Contacts

Tammy Clark

3042935264tclark@hsc.wvu.edu

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Melanie Nelson

608-265-4617mnelson@pediatrics.wisc.edu

More Information

Sponsor

Nicole Hamblett

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • ineligible and/or not taking CFTR modulators
  • People with CF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nicole Hamblett on 2025-10-01.