Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study
Public ClinicalTrials.gov record NCT06350474. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Master Protocol to Test the Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy - Dornase Alfa (Dnase)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking dornase alfa (Dnase) in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI). ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function. Dornase alfa (Dnase) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. Dnase is considered to be relatively burdensome and it is not known whether Dnase can improve or maintain lung function above what is already gained through ETI use. The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop Dnase by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking Dnase as compared to those who are assigned to keep taking Dnase while continuing to take ETI. This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153. The sub study investigating the impact of discontinuing and continuing hypertonic saline is registered under NCT06350461.
Study identification
- NCT ID
- NCT06350474
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 477 participants
Conditions and interventions
Conditions
Interventions
Other
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 25, 2020 (Actual)
- Primary completion
- Jul 11, 2022 (Actual)
- Completion
- Jul 11, 2022 (Actual)
- Last update posted
- Nov 26, 2024
2020 – 2022
United States locations
- U.S. sites
- 81
- U.S. states
- 38
- U.S. cities
- 72
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Tucson Cystic Fibrosis Center | Tucson | Arizona | 85724 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | — |
| CHOC Children's Hospital | Orange | California | 92868 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Rady Children's Hospital and Health Center at the University of California San Diego | San Diego | California | 92123 | — |
| University of California, San Francisco - Adult Center | San Francisco | California | 94143 | — |
| University of California, San Francisco - Peds Center | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | 32207 | — |
| Central Florida Pulmonary Group | Orlando | Florida | 32803 | — |
| The Nemours Children's Clinic - Orlando | Orlando | Florida | 32827 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32514 | — |
| All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Emory University | Atlanta | Georgia | 30324 | — |
| Saint Luke's Cystic Fibrosis Center of Idaho | Boise | Idaho | 83702 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kentucky | Lexington | Kentucky | 40506 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tulane University | Metairie | Louisiana | 70001 | — |
| Maine Medical Partners Pediatric Specialty Care | Portland | Maine | 04102 | — |
| John Hopkins Hospital | Baltimore | Maryland | 21205 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan, Michigan Medicine | Ann Arbor | Michigan | 48109 | — |
| Wayne State University Harper University Hospital | Detroit | Michigan | 48201 | — |
| Corewell Health Helen DeVos | Grand Rapids | Michigan | 49546 | — |
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| The Minnesota Cystic Fibrosis Center | Minneapolis | Minnesota | 55455 | — |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Monmouth Medical Center | Eatontown | New Jersey | 07724 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | — |
| Cohen Children's Medical Center of New York | New Hyde Park | New York | 11042 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Lenox Hill Hospital Cystic Fibrosis Center | New York | New York | 10028 | — |
| Columbia University Cystic Fibrosis Program | New York | New York | 10032 | — |
| University of Rochester Medical Center Strong Memorial | Rochester | New York | 14642 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| New York Medical College at Westchester Medical Center | Valhalla | New York | 10595 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | — |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44146 | — |
| Cleveland Clinic Cystic Fibrosis Program | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| Oregon Health & Sciences University | Portland | Oregon | 97239 | — |
| Hershey Medical Center Pennsylvania State University | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| University of Texas Southwestern / Children's Health | Dallas | Texas | 75207 | — |
| University of Texas Southwestern | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| University of Texas Health Center at Tyler | Tyler | Texas | 75708 | — |
| Primary Children's Cystic Fibrosis Center | Salt Lake City | Utah | 84113 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Virginia | Charlottesville | Virginia | 22904 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Providence Medical Group, Cystic Fibrosis Center | Spokane | Washington | 99204 | — |
| West Virginia University - Morgantown | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
| Children's Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06350474, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 26, 2024 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06350474 live on ClinicalTrials.gov.