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New study aims to speed up CF drug development for those without modulators

NCT ID NCT06504589

Knowledge-focused Sponsor: Nicole Hamblett Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people with cystic fibrosis (CF) who do not take CFTR modulators. Researchers will collect health information and samples over 12 months from 400 participants aged 12 and older. The goal is to use this data to design better clinical trials and develop new treatments for this group. Participants will also learn what it's like to be in a research study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    68 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adult Cystic Fibrosis Center at the University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Billings Clinic

    RECRUITING

    Billings, Montana, 59101, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Central Florida Pulmonary Group

    RECRUITING

    Orlando, Florida, 32803, United States

  • Children's Healthcare of Atlanta and Emory University

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Childrens Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic Cystic Fibrosis Program

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cohen Children's Medical Center of New York

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Columbia University Cystic Fibrosis Program

    RECRUITING

    New York, New York, 10032, United States

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Corewell Health Helen DeVos

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Dell Children's Medical Center of Central Texas

    RECRUITING

    Austin, Texas, 78723, United States

  • Hershey Medical Center Pennsylvania State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Inova L.J. Murphy Pediatric CF Program

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • John Hopkins Hospital

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • New York Medical College at Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oregon Health & Sciences University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Prisma Health Children's Hospital - Midlands

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Providence Medical Group, Cystic Fibrosis Clinic

    RECRUITING

    Spokane, Washington, 99204, United States

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

    RECRUITING

    Cleveland, Ohio, 44106, United States

    Contact Email: •••••@•••••

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Saint Luke's Cystic Fibrosis Center of Idaho

    RECRUITING

    Boise, Idaho, 83702, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

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

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • The Cystic Fibrosis Center of Western New York

    NOT_YET_RECRUITING

    Buffalo, New York, 14203, United States

  • The Minnesota Cystic Fibrosis Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Tucson Cystic Fibrosis Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • Tulane University

    RECRUITING

    Metairie, Louisiana, 70001, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California San Diego

    NOT_YET_RECRUITING

    La Jolla, California, 92093, United States

  • University of California, San Francisco - Adult Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of California, San Francisco - Peds Center

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

  • University of Massachusetts Memorial Health Care

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan, Michigan Medicine

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 69198, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Rochester Medical Center Strong Memorial

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Texas Southwestern / Children's Health

    RECRUITING

    Dallas, Texas, 75207, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Wayne State University Harper University Hospital

    RECRUITING

    Detroit, Michigan, 48201, United States

  • West Virginia University - Morgantown

    RECRUITING

    Morgantown, West Virginia, 26507, United States

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Other studies related to the condition(s) this trial covers.