Rethinking Early Airway Clearence Therapies

What this study is about

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 (things the study team will check)

✅ You may be able to join if…

• 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

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

🚫 You may not be able to join if…

• 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
• 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)

Where this trial is running

• 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

+ 27 more sites.

Who to contact

Rachael Buckingham · 206-884-7517 · rachael.buckingham@seattlechildrens.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07696338.