NCT07696338Not yet recruiting
Rethinking Early Airway Clearence Therapies
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
The REACT trial consists of two parallel, randomized studies; the Hypertonic Saline Study and the Dornase Alfa Study. Health outcomes among people with cystic fibrosis (CF) have been steadily improving, most recently with the advent of highly effective modulator therapy (HEMT). While therapies like hypertonic saline (HS) and dornase alfa (DA) improved outcomes in the past, they are often burdensome. Now that almost 90% of the North American CF population is being treated with elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD), this trial will evaluate whether these newer treatments make daily HS or DA unnecessary. The trial begins with a 6-week run-in period where participants continue ETI or VTD but stop using HS and DA. Eligible participants are then assigned to either the HS Study or the DA Study for one year. Within those groups, they are randomized to either daily use of HS or DA or as needed use only during respiratory illnesses. The study aims to find out if lung health is similar between children and teens taking HEMT who use HS or DA treatments daily and those who use HS or DA treatments only when they are sick.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 405 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 28 Feb 2030
- Lead sponsor
- Nicole Hamblett
- Diseases
- Cystic fibrosis
- NCT number
- NCT07696338
What you commit to
- Study type: Interventional
- Planned participants: 405
- From 15 Sept 2026 to the primary completion date, 28 Feb 2030
- 39 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No use of an investigational drug within 28 days prior to and including Screening Visit
- No initiation of new chronic therapy (e.g., azithromycin, inhaled tobramycin, inhaled aztreonam) within 28 days prior to and including Screening Visit
- 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 Screening Visit
- No antibiotic treatment for nontuberculous mycobacteria (NTM) within 28 days prior to and including the Screening Visit
- No acute use of antibiotics (oral, inhaled or IV), systemic corticosteroids, hypertonic saline, or dornase alfa for respiratory tract symptoms within 28 days prior to and including Visit 1
Other
- No absolute decrease in FEV1 % predicted of ≥10% from the Screening Visit to Visit 1 (in participants who performed acceptable and reproducible spirometry at both visits)
Who the study is looking for
- All genders ≥ 3 and ≤ 16 years of age
- Documentation of a CF diagnosis
- If capable of completing spirometry, forced expiratory volume in 1 second (FEV1) ≥ 70 % predicted at the Screening Visit
- Clinically stable with no significant changes in health status within the 28 days prior to and including Screening Visit
- MBW test meets acceptability criteria at the Screening Visit
- On elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD) for at least 90 days prior to and including Screening (modified dose permissible) and willing to continue daily use of either ETI or VTD for the duration of the study
- Clinically stable with no significant changes in health status for 28 days prior to Visit 1
- MBW test meets acceptability at Visit 1
- Completed at least 60% of weekly electronic treatment diaries
- Take at least one dose of ETI or VTD per weekly electronic treatment diaries
Age in the registry: 3 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Elizabeth II Hospital Halifax Adult CF Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| CF Centre Hospital for Sick Children (Toronto, ON) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| CF Centre BC Children's Hospital (Vancouver, Canada) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of Michigan - Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Children's Healthcare of Atlanta and Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| John Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| The Children's Hospital Alabama & University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern, Children's Health Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Children's Mercy Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Childrens Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Children's Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Children's Hospitals and Clinics of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| The Minnesota Cystic Fibrosis Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| CHOC Children's Hospital Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Stanford University Medical Center Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Rochester Medical Center Strong Memorial Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| St. Louis Children's Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Tucson Cystic Fibrosis Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.