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Rethinking Early Airway Clearence Therapies
Sponsor: Nicole Hamblett
Summary
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.
Key Details
Gender
All
Age Range
3 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
405
Start Date
2026-09-15
Completion Date
2030-02-28
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
As-needed hypertonic saline (HS)
As-needed hypertonic saline (HS) therapy during the 52-week study period.
Twice daily hypertonic saline (HS)
Twice daily hypertonic saline (HS) therapy during the 52-week study period. The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride).
As-needed dornase alfa (DA)
As-needed dornase alfa (DA) therapy during the 52-week study period.
Daily dornase alfa (DA)
Daily dornase alfa (DA) during the 52-week study period.
Locations (39)
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States
Tucson Cystic Fibrosis Center
Tucson, Arizona, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
CHOC Children's Hospital
Orange, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
University of Rochester Medical Center Strong Memorial
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern / Children's Health
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
CF Centre BC Children's Hospital (Vancouver, Canada)
Vancouver, British Columbia, Canada
Queen Elizabeth II Hospital Halifax Adult CF Centre
Halifax, Nova Scotia, Canada
CF Centre Hospital for Sick Children (Toronto, ON)
Toronto, Ontario, Canada