Hypertonic Saline + Dornase Alfa for Cystic Fibrosis
(REACT Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Margaret Rosenfeld, MD, MPH
Principal Investigator
University of Washington, Seattle Children's Research Institute
Felix Ratjen, MD, PhD
Principal Investigator
University of Toronto, SickKids Research Institute
Jonathan Rayment, MDCM, MSc, FRCPC
Principal Investigator
University of British Columbia, BC Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children and teens with cystic fibrosis who are already taking highly effective modulator therapy (like ETI or VTD). Participants must be able to stop using hypertonic saline and dornase alfa for a short period before the study begins.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants continue ETI or VTD but stop using HS and DA
Treatment
Participants are randomized to either daily or as-needed use of HS or DA
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dornase Alfa (DA)
- Hypertonic Saline (HS)
Trial Overview
The study compares daily versus as-needed use of two airway clearance treatments—hypertonic saline and dornase alfa—in kids and teens with CF who are on modern modulator therapies. Participants are randomly assigned to one of these approaches for a year.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
As-needed hypertonic saline (HS) therapy in the HS Study
As-needed dornase alfa (DA) therapy in the DA Study
Twice daily hypertonic saline (HS) therapy in the HS Study
Daily dornase alfa (DA) therapy in the DA Study
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nicole Hamblett
Lead Sponsor
Cystic Fibrosis Foundation
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.