Rethinking Early Airway Clearence Therapies

Summary

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.

Conditions

• Cystic Fibrosis (CF)

Interventions

OTHER

As-needed hypertonic saline (HS)

As-needed hypertonic saline (HS) therapy during the 52-week study period.

OTHER

Twice daily hypertonic saline (HS)

Twice daily hypertonic saline (HS) therapy during the 52-week study period. The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride).

OTHER

As-needed dornase alfa (DA)

As-needed dornase alfa (DA) therapy during the 52-week study period.

OTHER

Daily dornase alfa (DA)

Daily dornase alfa (DA) during the 52-week study period.

Sponsors & Collaborators

• Cystic Fibrosis Foundation

  collaborator OTHER

• Nicole Hamblett

  lead OTHER

Principal Investigators

• Margaret Rosenfeld, MD, MPH · University of Washington, Seattle Children's Research Institute

• Felix Ratjen, MD, PhD · University of Toronto, SickKids Research Institute

• Jonathan Rayment, MDCM, MSc, FRCPC · University of British Columbia, BC Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2030-02-28

Completion

2030-02-28

Countries

• United States
• Canada

Study Locations