About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- As-needed hypertonic saline (HS)
- Twice daily hypertonic saline (HS)
- As-needed dornase alfa (DA)
- Daily dornase alfa (DA)
Treatment groups
Sponsors and collaborators
Nicole Hamblett
Lead sponsor
Seattle Children's Hospital
Sponsor institution
Cystic Fibrosis Foundation
Collaborator