Hypertonic Saline + Dornase Alfa for Cystic Fibrosis

(REACT Trial)

Not yet recruiting at 38 trial locations
RB
AM
Overseen ByAnna Mead
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Nicole Hamblett
Must be taking: Elexacaftor/tezacaftor/ivacaftor, Vanzacaftor/tezacaftor/deutivacaftor
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

MR

Margaret Rosenfeld, MD, MPH

Principal Investigator

University of Washington, Seattle Children's Research Institute

FR

Felix Ratjen, MD, PhD

Principal Investigator

University of Toronto, SickKids Research Institute

JR

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

My lung function test shows my FEV1 is at least 70% of what is expected for me.
I have taken at least one dose of ETI or VTD as recorded in my treatment diary.
Clinically stable with no significant changes in health status within the 28 days prior to and including Screening Visit
See 7 more

Exclusion Criteria

I have not used antibiotics or steroids for breathing problems in the past 28 days.
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
I have not taken any investigational drugs in the past 28 days.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants continue ETI or VTD but stop using HS and DA

6 weeks

Treatment

Participants are randomized to either daily or as-needed use of HS or DA

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: As-Needed HSExperimental Treatment1 Intervention
Group II: As-Needed DAExperimental Treatment1 Intervention
Group III: Daily HSActive Control1 Intervention
Group IV: Daily DAActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nicole Hamblett

Lead Sponsor

Trials
7
Recruited
7,900+

Cystic Fibrosis Foundation

Collaborator

Trials
199
Recruited
37,800+