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NCT07696338Not yet recruiting

Rethinking Early Airway Clearence Therapies

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
405 (estimated)
First submitted
6 Jul 2026
Start date
15 Sept 2026
Primary completion date
28 Feb 2030
Lead sponsor
Nicole Hamblett
NCT number
NCT07696338

What you commit to

  • Study type: Interventional
  • Planned participants: 405
  • From 15 Sept 2026 to the primary completion date, 28 Feb 2030
  • 39 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • 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)

Who the study is looking for

  • 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

Age in the registry: 3 years to 16 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Queen Elizabeth II Hospital Halifax Adult CF Centre
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
CF Centre Hospital for Sick Children (Toronto, ON)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
CF Centre BC Children's Hospital (Vancouver, Canada)
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
University of Michigan - Michigan Medicine
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Ann ArborUnited StatesUnknown status
Children's Healthcare of Atlanta and Emory University
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AtlantaUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
John Hopkins Hospital
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BaltimoreUnited StatesUnknown status
The Children's Hospital Alabama & University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical Center
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ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
University of Texas Southwestern, Children's Health
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DallasUnited StatesUnknown status
Dayton Children's Hospital
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DaytonUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
Riley Hospital for Children
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IndianapolisUnited StatesUnknown status
University of Iowa
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Iowa CityUnited StatesUnknown status
Children's Mercy Kansas City
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Kansas CityUnited StatesUnknown status
Childrens Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
University of Wisconsin
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MadisonUnited StatesUnknown status
Children's Wisconsin
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MilwaukeeUnited StatesUnknown status
Children's Hospitals and Clinics of Minnesota
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MinneapolisUnited StatesUnknown status
The Minnesota Cystic Fibrosis Center
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MinneapolisUnited StatesUnknown status
CHOC Children's Hospital
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OrangeUnited StatesUnknown status
Stanford University Medical Center
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Palo AltoUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesUnknown status
Oregon Health Sciences University
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PortlandUnited StatesUnknown status
Virginia Commonwealth University
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RichmondUnited StatesUnknown status
University of Rochester Medical Center Strong Memorial
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RochesterUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status
Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics
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SpokaneUnited StatesUnknown status
St. Louis Children's Hospital
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St LouisUnited StatesUnknown status
All Children's Hospital
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St. PetersburgUnited StatesUnknown status
Tucson Cystic Fibrosis Center
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TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.