이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Rethinking Early Airway Clearence Therapies (REACT)

2026년 7월 6일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

405

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: As-Needed HS
As-needed hypertonic saline (HS) therapy in the HS Study
다른: As-needed hypertonic saline (HS)
As-needed hypertonic saline (HS) therapy during the 52-week study period.
활성 비교기: Daily HS
Twice daily hypertonic saline (HS) therapy in the HS Study
다른: 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).
실험적: As-Needed DA
As-needed dornase alfa (DA) therapy in the DA Study
다른: As-needed dornase alfa (DA)
As-needed dornase alfa (DA) therapy during the 52-week study period.
활성 비교기: Daily DA
Daily dornase alfa (DA) therapy in the DA Study
다른: Daily dornase alfa (DA)
Daily dornase alfa (DA) during the 52-week study period.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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.
기간: 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
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nicole Hamblett

협력자

Cystic Fibrosis Foundation

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 15일

기본 완료 (추정된)

2030년 2월 28일

연구 완료 (추정된)

2030년 2월 28일

연구 등록 날짜

최초 제출

2026년 7월 6일

QC 기준을 충족하는 최초 제출

2026년 7월 6일

처음 게시됨 (실제)

2026년 7월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 6일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • REACT-IP-25

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다