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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.

Key facts

Who runs it
Nicole Hamblett
Where
Ann Arbor, Atlanta, Aurora, Baltimore, Birmingham, Boston, Chapel Hill, Charleston, Charlottesville, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Dayton, Houston, Indianapolis, Iowa City, Kansas City, Los Angeles, Madison, Milwaukee, Minneapolis, Orange, Palo Alto, Philadelphia, Pittsburgh, Portland, Richmond, Rochester, Seattle, Spokane, St Louis, St. Petersburg, and Tucson, United StatesSee the 36 sitesAlso in 1 other country, 3 sites
Trial code
Registry title
Rethinking Early Airway Clearence Therapies
Status
Not yet recruiting
People taking part
405 people, planned
Started
15 Sept 2026
Expected to end
28 Feb 2030
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • As-needed hypertonic saline (HS)
  • Twice daily hypertonic saline (HS)
  • As-needed dornase alfa (DA)
  • Daily dornase alfa (DA)
Record updated
10 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teens with cystic fibrosis who already take ETI or VTD. It tests daily versus only-when-sick hypertonic saline or dornase alfa.

Age
3 to 16 years
Sex
All genders
Disease stage
Documented cystic fibrosis, clinically stable for 28 days. If able to do spirometry, FEV1 at least 70% predicted.
Earlier treatment
Must have taken elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD) for at least 90 days and be willing to keep taking it daily during the study.

Main reasons for not taking part

  • Used an investigational drug within 28 days before screening
  • Started a new long-term therapy (for example azithromycin, inhaled tobramycin, inhaled aztreonam) within 28 days
  • Took antibiotics or systemic corticosteroids for breathing symptoms within 28 days
  • Had antibiotic treatment for nontuberculous mycobacteria within 28 days
  • FEV1 % predicted dropped by 10% or more between screening and Visit 1

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Check if you might fit

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?

Where in United States

Also in 1 other country, 3 sites

  • University of Michigan - Michigan MedicineAnn Arbor, United StatesContact: Dawn KruseNot yet recruiting
  • Children's Healthcare of Atlanta and Emory UniversityAtlanta, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Children's Hospital ColoradoAurora, United StatesContact: Rachael BuckinghamNot yet recruiting
  • John Hopkins HospitalBaltimore, United StatesContact: Rachael BuckinghamNot yet recruiting
  • The Children's Hospital Alabama & University of Alabama at BirminghamBirmingham, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Boston Children's HospitalBoston, United StatesContact: Rachael BuckinghamNot yet recruiting
  • University of North Carolina at Chapel HillChapel Hill, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Medical University of South CarolinaCharleston, United StatesContact: Sarah ShineNot yet recruiting
  • University of VirginiaCharlottesville, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesContact: Mary RiordanNot yet recruiting
  • Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Rainbow Babies and Children's Hospital / University Hospitals Cleveland Medical CenterCleveland, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Nationwide Children's HospitalColumbus, United StatesContact: Rachael BuckinghamNot yet recruiting
  • University of Texas Southwestern, Children's HealthDallas, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Dayton Children's HospitalDayton, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Baylor College of MedicineHouston, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Riley Hospital for ChildrenIndianapolis, United StatesContact: Rachael BuckinghamNot yet recruiting
  • University of IowaIowa City, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Children's Mercy Kansas CityKansas City, United StatesContact: Jana LamonteNot yet recruiting
  • Childrens Hospital Los AngelesLos Angeles, United StatesContact: Rachael BuckinghamNot yet recruiting
  • University of WisconsinMadison, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Children's WisconsinMilwaukee, United StatesContact: Laura RothNot yet recruiting
  • Children's Hospitals and Clinics of MinnesotaMinneapolis, United StatesContact: Elizabeth Franck ThompsonNot yet recruiting
  • The Minnesota Cystic Fibrosis CenterMinneapolis, United StatesContact: Rachael BuckinghamNot yet recruiting
  • CHOC Children's HospitalOrange, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Stanford University Medical CenterPalo Alto, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesContact: Adrienne DeRiccoNot yet recruiting
  • Oregon Health Sciences UniversityPortland, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Virginia Commonwealth UniversityRichmond, United StatesContact: Rachael BuckinghamNot yet recruiting
  • University of Rochester Medical Center Strong MemorialRochester, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Seattle Children's HospitalSeattle, United StatesContact: Dawn BatchuluunNot yet recruiting
  • Providence Medical Group, Cystic Fibrosis Clinic - PediatricsSpokane, United StatesContact: Lauren WilcoxNot yet recruiting
  • St. Louis Children's HospitalSt Louis, United StatesContact: Rachael BuckinghamNot yet recruiting
  • All Children's HospitalSt. Petersburg, United StatesContact: Rachael BuckinghamNot yet recruiting
  • Tucson Cystic Fibrosis CenterTucson, United StatesContact: Rachael BuckinghamNot yet recruiting

About the trial

What the trial wants to find out

The REACT trial consists of two parallel, randomized studies; the Hypertonic Saline Study and the Dornase Alfa Study.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • As-Needed HSTreatment being tested

    As-needed hypertonic saline (HS) therapy in the HS Study

    Treatment: As-needed hypertonic saline (HS)

  • Daily HSExisting treatment, for comparison

    Twice daily hypertonic saline (HS) therapy in the HS Study

    Treatment: Twice daily hypertonic saline (HS)

  • As-Needed DATreatment being tested

    As-needed dornase alfa (DA) therapy in the DA Study

    Treatment: As-needed dornase alfa (DA)

  • Daily DAExisting treatment, for comparison

    Daily dornase alfa (DA) therapy in the DA Study

    Treatment: Daily dornase alfa (DA)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Rethinking Early Airway Clearence Therapies
Plain-language title
Daily or As-Needed Airway Clearance Treatments for Children and Teens With Cystic FibrosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07696338, who can take part
Record updated
10 July 2026