Daily or As-Needed Airway Clearance Treatments for Children and Teens With Cystic Fibrosis
Compares daily versus as-needed hypertonic saline or dornase alfa in young people with cystic fibrosis.
Plain-language title generated from the registry record
Registry title: Rethinking Early Airway Clearence Therapies
Key facts
- Where
- Halifax, Toronto, and Vancouver, CanadaSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 16 years old?
Source: NCT07696338, who can take part
Where in Canada
- Queen Elizabeth II Hospital Halifax Adult CF CentreHalifax, CanadaNo longer taking part
- CF Centre Hospital for Sick Children (Toronto, ON)Toronto, CanadaNo longer taking part
- CF Centre BC Children's Hospital (Vancouver, Canada)Vancouver, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nicole Hamblett
- Trial code
- NCT07696338
- Record updated
- 10 July 2026
- Original description
The REACT trial consists of two parallel, randomized studies; the Hypertonic Saline Study and the Dornase Alfa Study.Read full original descriptionShow less
Rethinking Early Airway Clearence Therapies
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.
Inclusion: 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; 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.
Exclusion: 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; 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).