Rethinking Early Airway Clearence Therapies (NCT07696338)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: The Children's Hospital Alabama, University of Alabama at Birmingham โ Birmingham, Alabama
Age range: 3 Years to 16 Years
๐งช Interventions in This Study
- As-needed hypertonic saline (HS) (OTHER)
- Twice daily hypertonic saline (HS) (OTHER)
- As-needed dornase alfa (DA) (OTHER)
- Daily dornase alfa (DA) (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (39 Sites)
Showing the first 25 of 39 sites.
- The Children's Hospital Alabama, University of Alabama at Birmingham โ Birmingham, Alabama
- Tucson Cystic Fibrosis Center โ Tucson, Arizona
- Childrens Hospital Los Angeles โ Los Angeles, California
- CHOC Children's Hospital โ Orange, California
- Stanford University Medical Center โ Palo Alto, California
- Children's Hospital Colorado โ Aurora, Colorado
- All Children's Hospital โ St. Petersburg, Florida
- Children's Healthcare of Atlanta and Emory University โ Atlanta, Georgia
- Ann & Robert H. Lurie Children's Hospital of Chicago โ Chicago, Illinois
- Riley Hospital for Children โ Indianapolis, Indiana
- University of Iowa โ Iowa City, Iowa
- John Hopkins Hospital โ Baltimore, Maryland
- Boston Children's Hospital โ Boston, Massachusetts
- University of Michigan, Michigan Medicine โ Ann Arbor, Michigan
- Children's Hospitals and Clinics of Minnesota โ Minneapolis, Minnesota
- The Minnesota Cystic Fibrosis Center โ Minneapolis, Minnesota
- Children's Mercy Kansas City โ Kansas City, Missouri
- St. Louis Children's Hospital โ St Louis, Missouri
- University of Rochester Medical Center Strong Memorial โ Rochester, New York
- University of North Carolina at Chapel Hill โ Chapel Hill, North Carolina
- Cincinnati Children's Hospital Medical Center โ Cincinnati, Ohio
- Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center โ Cleveland, Ohio
- Nationwide Children's Hospital โ Columbus, Ohio
- Dayton Children's Hospital โ Dayton, Ohio
- Oregon Health & Sciences University โ Portland, Oregon
๐ Contact the Study Coordinator
Phone: (206) 884-7517
Email: rachael.buckingham@seattlechildrens.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cystic Fibrosis (CF)
- Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta โ Denver, Colorado
- Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care โ Santa Ana, California
- MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure . โ Toronto, Ontario
- Nutrition Supplement for Cystic Fibrosis โ Columbus, Ohio
- Study to Enable New Diagnostics for Pulmonary Microbes in People With CF โ La Jolla, California
Explore by condition: All Cystic Fibrosis (CF) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.