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Rethinking Early Airway Clearence Therapies (REACT)

6 juli 2026 uppdaterad av: Nicole Hamblett

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Health outcomes among people with cystic fibrosis (CF) have been steadily improving for decades through guideline-directed multi-disciplinary clinical care models, expanding CF-specific therapies, and, most recently, the advent of highly effective modulator therapies (HEMT). Chronic therapies such as hypertonic saline (HS) and dornase alfa (DA) were associated with improved outcomes in the pre-modulator era but are also burdensome and costly. Now that almost 90% of the North American CF population is being treated with elexacaftor/tezacaftor/ivacaftor (ETI) or vanzacaftor/tezacaftor/deutivacaftor (VTD), many in the CF community are asking if chronic inhaled therapies such as HS or DA can be stopped or not started (in young children). Indeed, many people with CF stably on ETI are already stopping or reducing these chronic inhaled mucoactive therapies (CIMT) without an evidence base to guide shared decision-making.

The REACT trial is a platform trial consisting of two parallel prospective, multicenter, randomized, open-label studies: the Hypertonic Saline (HS) Study and the Dornase Alfa (DA) Study. In the Hypertonic Saline (HS) Study, participants will be randomized to twice-daily inhaled HS or as-needed HS (with acute respiratory illnesses, if considered indicated) for one year. In the Dornase Alfa (DA) Study, participants will be randomized to daily inhaled DA or as-needed DA (with acute respiratory illnesses, if considered indicated) for one year.

Study participation will begin with a 6-week run-in period, during which participants who currently use HS, DA, or both will be instructed to stop these therapies; those who do not use chronic inhaled mucoactive therapies (CIMT) will be instructed to remain off these therapies. At the end of the run-in, eligible participants will be enrolled and assigned first to the HS or DA Study and then randomized to study arm. Participants who use only HS or no CIMT at study entry will be assigned to the HS Study. Those who use DA only at study entry will be assigned to the DA Study. Those who use both HS and DA will be randomly assigned to the HS or DA Study. Participants will be instructed to continue their mechanical airway clearance and inhaled antibiotics (if applicable) as prescribed at study entry. Those who were on both HS and DA at study entry will be instructed to only use the inhaled mucoactive agent to which they have been assigned (HS or DA). Participants randomized to the as-needed arm will be allowed to use the study inhaled agent (HS or DA) temporarily, if considered indicated, with acute respiratory illnesses. Participants in either arm will be allowed to (re)introduce chronic daily therapy if felt to be indicated by the treating physician.

Studietyp

Interventionell

Inskrivning (Beräknad)

405

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • The Children's Hospital Alabama, University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85724
        • Tucson Cystic Fibrosis Center
    • California
      • Los Angeles, California, Förenta staterna, 90027
        • Childrens Hospital Los Angeles
      • Orange, California, Förenta staterna, 92868
        • CHOC Children's Hospital
      • Palo Alto, California, Förenta staterna, 94025
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Children's Hospital Colorado
    • Florida
      • St. Petersburg, Florida, Förenta staterna, 33701
        • All Children's Hospital
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Children's Healthcare of Atlanta and Emory University
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Riley Hospital for Children
    • Iowa
      • Iowa City, Iowa, Förenta staterna, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21287
        • John Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • University of Michigan, Michigan Medicine
        • Kontakt:
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55404
      • Minneapolis, Minnesota, Förenta staterna, 55455
        • The Minnesota Cystic Fibrosis Center
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64108
        • Children's Mercy Kansas City
        • Kontakt:
      • St Louis, Missouri, Förenta staterna, 63110
        • St. Louis Children's Hospital
    • New York
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester Medical Center Strong Memorial
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, Förenta staterna, 44106
        • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
      • Columbus, Ohio, Förenta staterna, 43205
        • Nationwide Children's Hospital
      • Dayton, Ohio, Förenta staterna, 45404
        • Dayton Children's Hospital
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • Oregon Health & Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Förenta staterna, 15224
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Medical University of South Carolina
        • Kontakt:
    • Texas
      • Dallas, Texas, Förenta staterna, 75207
        • University of Texas Southwestern / Children's Health
      • Houston, Texas, Förenta staterna, 77030
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22904
        • University of Virginia
      • Richmond, Virginia, Förenta staterna, 23219
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, Förenta staterna, 98105
      • Spokane, Washington, Förenta staterna, 99204
        • Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics
        • Kontakt:
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Children's Wisconsin
        • Kontakt:
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6H3V4
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada
        • Queen Elizabeth II Hospital Halifax Adult CF Centre
        • Kontakt:
    • Ontario
      • Toronto, Ontario, Kanada, M5G1X8

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria at Screening:

  • 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

Inclusion Criteria at Randomization:

  • 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 Criteria at Screening:

  • 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

Exclusion Criteria at Visit 1:

  • 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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: As-Needed HS
As-needed hypertonic saline (HS) therapy in the HS Study
Övrig: As-needed hypertonic saline (HS)
As-needed hypertonic saline (HS) therapy during the 52-week study period.
Aktiv komparator: Daily HS
Twice daily hypertonic saline (HS) therapy in the HS Study
Övrig: 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).
Experimentell: As-Needed DA
As-needed dornase alfa (DA) therapy in the DA Study
Övrig: As-needed dornase alfa (DA)
As-needed dornase alfa (DA) therapy during the 52-week study period.
Aktiv komparator: Daily DA
Daily dornase alfa (DA) therapy in the DA Study
Övrig: Daily dornase alfa (DA)
Daily dornase alfa (DA) during the 52-week study period.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute Change in Lung Clearance Index (LCI) through Week 52, Relative to Week 0, in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 52 weeks
Difference in the change in lung clearance index through Week 52, relative to Week 0, between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
52 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) through Week 52, Relative to Week 0, in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 52 weeks
Difference in the change in percent predicted forced expiratory volume in 1 second through Week 52, relative to Week 0, between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
52 weeks
Rate of Protocol-Defined Pulmonary Exacerbations (PEx) through Week 52 in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 52 weeks
Difference in the rate of protocol-defined pulmonary exacerbations (PEx) through Week 52 between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
52 weeks
Absolute Change in Respiratory Symptoms, as Measured by the Cystic Fibrosis Questionnaire - Revised Respiratory Domain (CFQ-R RD), through Week 52, Relative to Week 0, in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms
Tidsram: 52 weeks
Difference in the change in the Cystic Fibrosis Questionnaire - Revised Respiratory Domain (CFQ-R RD) through Week 52, relative to Week 0, between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
52 weeks
Absolute Change in Lung Clearance Index (LCI) from Week 0 to Week 6 in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 6 weeks
Difference in the change in the lung clearance index (LCI) from Week 0 to Week 6 between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
6 weeks
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) from Week 0 to Week 6 in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 6 weeks
Difference in the change in the percent predicted forced expiratory volume in 1 second (ppFEV1) from Week 0 to Week 6 between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed.
6 weeks
Absolute Change in Respiratory Symptoms, as Measured by the Cystic Fibrosis Questionnaire - Revised Respiratory Domain (CFQ-R RD), from Week 0 to Week 6 in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 6 weeks
Difference in the change in the Cystic Fibrosis Questionnaire - Revised Respiratory Domain (CFQ-R RD) from Week 0 to Week 6 between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
6 weeks
Absolute Change in Treatment Burden, as Measured by the Cystic Fibrosis Questionnaire - Revised Treatment Burden Domain, through Week 52, Relative to Week 0, in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 52 weeks
Difference in the change in the Cystic Fibrosis Questionnaire - Revised Treatment Burden domain through Week 52, relative to Week 0, between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
52 weeks
Absolute Change in Family Impact, as Measured by the Pediatric Quality of Life Inventory (PedsQL) Family Impact Module, through Week 52, Relative to Week 0, in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 52 weeks
Difference in the change in the Pediatric Quality of Life Inventory (PedsQL) Family Impact Module through Week 52, relative to Week 0, between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS Entire Concurrently Eligible (ECE) cohort) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA ECE cohort). Participants included in the as-needed HS ECE are those who had a non-zero probability of being assigned to the HS Study and were randomized to either the as-needed HS arm (HS Study) or the as-needed DA arm (DA Study).
52 weeks
Healthcare Resource Utilization (HCRU) through Week 52 in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 52 weeks
Difference in the Healthcare Resource Utilization (HCRU) through Week 52 between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA).
52 weeks
Incremental cost-effectiveness ratios (ICERs) through Week 52 in Hypertonic Saline (HS Study) and Dornase Alfa (DA Study) Therapy Arms.
Tidsram: 52 weeks
Difference in the change in the Incremental cost-effectiveness ratios (ICERs) through Week 52 between hypertonic saline (HS) therapy arms (twice daily HS - as-needed HS) and between dornase alfa (DA) therapy arms (daily DA - as-needed DA).
52 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nicole Hamblett

Samarbetspartners

Cystic Fibrosis Foundation

Utredare

  • Huvudutredare: Margaret Rosenfeld, MD, MPH, University of Washington, Seattle Children's Research Institute
  • Huvudutredare: Felix Ratjen, MD, PhD, University of Toronto, SickKids Research Institute
  • Huvudutredare: Jonathan Rayment, MDCM, MSc, FRCPC, University of British Columbia, BC Children's Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 september 2026

Primärt slutförande (Beräknad)

28 februari 2030

Avslutad studie (Beräknad)

28 februari 2030

Studieregistreringsdatum

Först inskickad

6 juli 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

10 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • REACT-IP-25

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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