๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-06

Rethinking Early Airway Clearence Therapies (NCT07696338)

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: Nicole Hamblett

๐Ÿฉบ 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

๐Ÿงช 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)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ“ž 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.

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—