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Massive study tracks sweat changes in 5000 CF patients on new drugs

NCT ID NCT03350828

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at 5000 people with cystic fibrosis who are already taking approved CFTR modulator medicines. Researchers measure sweat chloride levels before and after treatment to see how the drugs affect the body. The goal is to better understand the link between sweat chloride changes and health outcomes.

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 5,000 people

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

Started

Jan 2018

Expected to finish

Dec 2026

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

Cystic Fibrosis Care Centers

Ages

4 months 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.

Inclusion Criteria: 1. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative 2. Enrolled in the CFFPR 3. Male or female ≥ 4 months of age on day of study visit 4. Diagnosis of CF. 5. Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment 6. Able to perform the testing and procedures required for this study, as judged by the investigator Additional Inclusion Criteria for CHEC-PKPD Sub-Study: 1. Male or female ≥ 6 years of age on day of study visit. 2. Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment. 3. Last dose of elexacaftor/tezacaftor/ivacaftor taken at least 24hours and last dose of ivacaftor taken at least 12 hours prior to trough blood draw on day of visit. Exclusion Criteria: 1. Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data 2. Currently enrolled in an investigational trial (including open-label follow-on studies and Early Access Programs (EAP) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)

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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

Contacts and locations

Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta and Emory University

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Children's Mercy Kansas City

    Kansas City, Missouri, 64108, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Emory University

    Atlanta, Georgia, 30327, United States

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • Hershey Medical Center Pennsylvania State University

    Hershey, Pennsylvania, 17033, United States

  • John Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32514, United States

  • New York Medical College at Westchester Medical Center

    Valhalla, New York, 10595, United States

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Primary Children's Cystic Fibrosis Center

    Salt Lake City, Utah, 84113, United States

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

    Cleveland, Ohio, 44106, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • SSM Health Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

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

    Birmingham, Alabama, 35233, United States

  • The Cystic Fibrosis Center of Western New York

    Buffalo, New York, 14203, United States

  • The Minnesota Cystic Fibrosis Center

    Minneapolis, Minnesota, 55455, United States

  • The Nemours Children's Clinic - Orlando

    Orlando, Florida, 32827, United States

  • Toledo Children's Hospital

    Toledo, Ohio, 43606, 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

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Michigan, Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517, United States

  • University of Tennessee CF Care and Research Center

    Memphis, Tennessee, 38103, United States

  • University of Texas Southwestern / Children's Health

    Dallas, Texas, 75207, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232, United States

  • West Virginia University - Morgantown

    Morgantown, West Virginia, 26506, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06520, United States

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