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Cystic FibrosisNCT06504589

A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators

An observational study of Cystic Fibrosis, run by Nicole Hamblett at 68 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Cystic Fibrosis
How many people
400 participants
Where
68 sitesUnited States
Study dates
18 Sep 2024to 14 Aug 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: People with CF who are ineligible and/or not taking an approved CFTR modulator and who are not receiving an investigational therapy.

Consent

  1. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian
  2. Is willing and able to adhere to the study visit schedule and other protocol requirements

Demographics

  1. ≥ 12 years of age at Visit 1

Medical History

  1. 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

  1. 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
  1. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1
  2. Does not have a history of lung transplantation

Concomitant Medications

  1. 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
  2. No use of an investigational drug within 90 days prior to and including Visit 1
  3. 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.
  4. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1
  5. 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

Trial locations and contacts

68 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olena Boyarska contact

206-884-1681

olena.boyarska@seattlechildrens.org

Anna Mead contact

206-884-7531

anna.mead@seattlechildrens.org

68 sites in 1 country

United States68 sites, 68 recruiting

  • University of Michigan, Michigan Medicine

    Ann Arbor, Michigan, 48109

    Dawn Kruse, 734-615-3266, dmkruse@med.umich.edu

    Recruiting

  • Children's Healthcare of Atlanta and Emory University

    Atlanta, Georgia, 30329

    Ashleigh Streby, 404-727-0305, ashleigh.streby@emory.edu

    Recruiting

  • Augusta University

    Augusta, Georgia, 30912

    Heidi Stapp, 706-721-7699, hstapp@augusta.edu

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Mary Cross, 720-777-4645, mary.cross@childrenscolorado.org

    Recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

    Kristina "Tina" Adrean, 512-324-9999, Kadrean@ascension.org

    Recruiting

  • John Hopkins Hospital

    Baltimore, Maryland, 21287

    Jeanne Pinto, 410-955-9782, jpinto4@jh.edu

    Not yet recruiting

  • Billings Clinic

    Billings, Montana, 59101

    Jerimiah Lysinger, 406-238-5137, JLysinger@billingsclinic.org

    Recruiting

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

    Birmingham, Alabama, 35233

    Kathryn Monroe, 205-638-5599, kathrynmonroe@uabmc.edu

    Recruiting

  • Saint Luke's Cystic Fibrosis Center of Idaho

    Boise, Idaho, 83702

    Lejla Godusevic, 208-381-4717, godusevl@slhs.org

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Margot Hardcastle, 617-726-3719, mhardcastle@mgh.harvard.edu

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Robert Fowler, 6173551834, Robert.fowler@childrens.harvard.edu

    Recruiting

  • The Cystic Fibrosis Center of Western New York

    Buffalo, New York, 14203

    Julianne Hergenroder, jhergenroder@upa.chob.edu

    Not yet recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Julie Goudy, 984-974-2364, julie_goudy@med.unc.edu

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Ashley Warden, 843-792-4349, jonesash@musc.edu

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Rachel Nelson, 312-695-0415, rachel.nelson@northwestern.edu

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

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

    Recruiting

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

    Cleveland, Ohio, 44106

    Primary RC & Participant Contact General Contact, RainbowCFResearch@UHhospitals.org

    Recruiting

  • Cleveland Clinic Cystic Fibrosis Program

    Cleveland, Ohio, 44195

    Dave Weaver, 216-445-6671, weaverd@ccf.org

    Not yet recruiting

  • Prisma Health Children's Hospital - Midlands

    Columbia, South Carolina, 29203

    Veronica Lipscomb, Veronica.Lipscomb@PrismaHealth.org

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

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

    Recruiting

  • University of Texas Southwestern / Children's Health

    Dallas, Texas, 75207

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

    Recruiting

  • University of Texas Southwestern

    Dallas, Texas, 75390

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

    Recruiting

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

    Amy Jones, 937-641-3693, Jonesa11@childrensdayton.org

    Recruiting

  • National Jewish Health

    Denver, Colorado, 80206

    Alix Wilson, 303-270-2517, wilsona@njhealth.org

    Recruiting

  • Wayne State University Harper University Hospital

    Detroit, Michigan, 48201

    Debra Driscoll, 313-745-2221, ddriscol@med.wayne.edu

    Recruiting

  • Inova L.J. Murphy Pediatric CF Program

    Fairfax, Virginia, 22031

    Colleen Mann, 703-776-6485, colleen.mann@inova.org

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Anna Reyes, 682-885-6589, anna.reyes@cookchildrens.org

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Chrystal Bailey, Cbailey1@peds.ufl.edu

    Recruiting

  • Corewell Health Helen DeVos

    Grand Rapids, Michigan, 49503

    Alicia Castillo Bahena, 6162679304, alicia.castillobahena@corewellhealth.org

    Recruiting

  • Hershey Medical Center Pennsylvania State University

    Hershey, Pennsylvania, 17033

    Diane M Kitch, 717-531-5646, dkitch@pennstatehealth.psu.edu

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Tracy Mosely, 832-822-3309, tlmosely@texaschildrens.org

    Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Lisa Bendy, 317-278-7152, lbendy@iupui.edu

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Lawrence Scott, 913-588-4020, lscott2@kumc.edu

    Recruiting

  • University of California San Diego

    La Jolla, California, 92093

    Jenna Mielke, 619-471-0822, jmielke@health.ucsd.edu

    Not yet recruiting

  • University of Kentucky

    Lexington, Kentucky, 40506

    Chase Whitaker, chase.whitaker@uky.edu

    859-218-4810

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Kathleen Hicks, 501-686-5527, HicksKathleenT@uams.edu

    Recruiting

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

    Carmen Reyes, 323-361-2662, mareyes@chla.usc.edu

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Melanie Nelson, 608-265-4617, mnelson@pediatrics.wisc.edu

    Recruiting

  • Tulane University

    Metairie, Louisiana, 70001

    Adrienne Savant, 504-896-9436, asavant1@tulane.edu

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Ylber (Ivan) Whitaker, 305-243-5545, yiw2@miami.edu

    Recruiting

  • The Minnesota Cystic Fibrosis Center

    Minneapolis, Minnesota, 55455

    CF Trials Contact University of Minnesota, Participant Contact, cftrials@umn.edu

    Recruiting

  • West Virginia University - Morgantown

    Morgantown, West Virginia, 26507

    Tammy Clark, 3042935264, tclark@hsc.wvu.edu

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

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

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Brijesh Patel, 615-343-4865, brijesh.patel@vumc.org

    Recruiting

  • Cohen Children's Medical Center of New York

    New Hyde Park, New York, 11042

    Susan Galvin, 516-321-8606, sgalvin@northwell.edu

    Recruiting

  • Columbia University Cystic Fibrosis Program

    New York, New York, 10032

    Emily DiMango, 212-305-0290, ead3@cumc.columbia.edu

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 69198

    Michel Veit, 402-559-7585, michel.veit@unmc.edu

    Recruiting

  • Central Florida Pulmonary Group

    Orlando, Florida, 32803

    Desiree Serr, 407-841-1100, dserr@cfpulmonary.com

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Jacquelyn Spano, 650-721-1132, jmzirbes@stanford.edu

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Erin Donnelly, 609-781-0307, Donnellye4@email.chop.edu

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Melissa Molter, 215-662-3116, melissa.molter@pennmedicine.upenn.edu

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    Natalia Argel, 602-933-0343, Nargel@phoenixchildrens.com

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15224

    Adrienne DeRicco, 4126928069, adrienne.dericco2@upmc.edu

    Recruiting

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

    Jenna Bucher, 503-494-7807, bucherj@ohsu.edu

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

    Akilah Pierre-Louis, akilah.pierrelouis1@vcuhealth.org

    Recruiting

  • University of Rochester Medical Center Strong Memorial

    Rochester, New York, 14642

    Barb Johnson, 585-276-4123, Barbara_Johnson@URMC.Rochester.edu

    Recruiting

  • Adult Cystic Fibrosis Center at the University of Utah

    Salt Lake City, Utah, 84112

    Kristyn Packer, 801-520-5106, kristyn.packer@hsc.utah.edu

    Recruiting

  • University of California, San Francisco - Adult Center

    San Francisco, California, 94143

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

    Recruiting

  • University of California, San Francisco - Peds Center

    San Francisco, California, 94158

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

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Sharon McNamara, 206-987-3921, sharon.mcnamara@seattlechildrens.org

    Recruiting

  • University of Washington Medical Center

    Seattle, Washington, 98195

    Lauren Bartlett, 503-583-2869, lrejman@uw.edu

    Recruiting

  • Providence Medical Group, Cystic Fibrosis Clinic

    Spokane, Washington, 99204

    Joan Milton, 509-474-4323, joan.milton@providence.org

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Irma Bauer, 314-747-2940, irmabauer@wustl.edu

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Andrew Marino, 813-844-4907, armarino@usf.edu

    Recruiting

  • Tucson Cystic Fibrosis Center

    Tucson, Arizona, 85724

    Elizabeth Ryan, 520-850-8688, elizabethryan@email.arizona.edu

    Recruiting

  • New York Medical College at Westchester Medical Center

    Valhalla, New York, 10595

    Zachary Messer, 914-594-2352, Zachary_Messer@nymc.edu

    Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

    Anna Pippins, apippins@wakehealth.edu

    Recruiting

  • University of Massachusetts Memorial Health Care

    Worcester, Massachusetts, 01655

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

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

People with Cystic Fibrosis (pwCF) who are genetically ineligible and/or not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulators currently face future health that is considerably different from the approximately 90% of pwCF in the United States who benefit from CFTR modulators. New treatments are being advanced for pwCF who are genetically ineligible or not taking CFTR modulators and these therapies will include both nucleic acid-based therapies (NABTs) to address the underlying defect in CFTR and symptomatic therapies aimed at targeting the symptoms of CF. A key concern for this limited and underserved patient population is being able to advance multiple therapeutic programs in parallel. To complete these studies, CF researchers will need to be able to reach this community effectively while also promoting the use of innovative trial designs.

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
Cystic Fibrosis
Keywords
ineligible and/or not taking CFTR modulators, People with CF
Medical subject headings
Cystic Fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Secondary outcomes (6)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start18 Sep 2024
  3. Primary completion14 Aug 2029 (estimated)
  4. Study completion14 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06504589
Sponsor's protocol ID
REACH-OB-23
Status last verified
Sep 2025
First submitted
27 Jun 2024
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cystic Fibrosis, run by Nicole Hamblett at 68 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olena Boyarska (206-884-1681, olena.boyarska@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ppFEV1 at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06504589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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