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Rethinking Early Airway Clearence Therapies (REACT)

2026年7月6日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

405

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35233
        • The Children's Hospital Alabama, University of Alabama at Birmingham
    • Arizona
      • Tucson、Arizona、アメリカ、85724
        • Tucson Cystic Fibrosis Center
    • California
      • Los Angeles、California、アメリカ、90027
        • Childrens Hospital Los Angeles
      • Orange、California、アメリカ、92868
        • CHOC Children's Hospital
      • Palo Alto、California、アメリカ、94025
        • Stanford University Medical Center
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • Children's Hospital Colorado
    • Florida
      • St. Petersburg、Florida、アメリカ、33701
        • All Children's Hospital
    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • Children's Healthcare of Atlanta and Emory University
    • Illinois
      • Chicago、Illinois、アメリカ、60611
    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • Riley Hospital for Children
    • Iowa
      • Iowa City、Iowa、アメリカ、52242
        • University of Iowa
    • Maryland
      • Baltimore、Maryland、アメリカ、21287
        • John Hopkins Hospital
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48109
        • University of Michigan, Michigan Medicine
        • コンタクト：
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55404
      • Minneapolis、Minnesota、アメリカ、55455
        • The Minnesota Cystic Fibrosis Center
    • Missouri
      • Kansas City、Missouri、アメリカ、64108
        • Children's Mercy Kansas City
        • コンタクト：
      • St Louis、Missouri、アメリカ、63110
        • St. Louis Children's Hospital
    • New York
      • Rochester、New York、アメリカ、14642
        • University of Rochester Medical Center Strong Memorial
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27599
    • Ohio
      • Cincinnati、Ohio、アメリカ、45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland、Ohio、アメリカ、44106
        • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
      • Columbus、Ohio、アメリカ、43205
        • Nationwide Children's Hospital
      • Dayton、Ohio、アメリカ、45404
        • Dayton Children's Hospital
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • Oregon Health & Sciences University
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • Children's Hospital of Philadelphia
      • Pittsburgh、Pennsylvania、アメリカ、15224
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • Medical University of South Carolina
        • コンタクト：
    • Texas
      • Dallas、Texas、アメリカ、75207
        • University of Texas Southwestern / Children's Health
      • Houston、Texas、アメリカ、77030
        • Baylor College of Medicine
    • Virginia
      • Charlottesville、Virginia、アメリカ、22904
        • University of Virginia
      • Richmond、Virginia、アメリカ、23219
        • Virginia Commonwealth University
    • Washington
      • Seattle、Washington、アメリカ、98105
      • Spokane、Washington、アメリカ、99204
        • Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics
        • コンタクト：
    • Wisconsin
      • Madison、Wisconsin、アメリカ、53792
        • University of Wisconsin
      • Milwaukee、Wisconsin、アメリカ、53226
        • Children's Wisconsin
        • コンタクト：
          • Laura Roth
          • 電話番号：414-266-3856
          • メール：lroth@mcw.edu
  • カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ、V6H3V4
        • CF Centre BC Children's Hospital (Vancouver, Canada)
        • コンタクト：
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ
        • Queen Elizabeth II Hospital Halifax Adult CF Centre
        • コンタクト：
    • Ontario
      • Toronto、Ontario、カナダ、M5G1X8

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：As-Needed HS
As-needed hypertonic saline (HS) therapy in the HS Study
他の：As-needed hypertonic saline (HS)
As-needed hypertonic saline (HS) therapy during the 52-week study period.
アクティブコンパレータ：Daily HS
Twice daily hypertonic saline (HS) therapy in the HS Study
他の：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).
実験的：As-Needed DA
As-needed dornase alfa (DA) therapy in the DA Study
他の：As-needed dornase alfa (DA)
As-needed dornase alfa (DA) therapy during the 52-week study period.
アクティブコンパレータ：Daily DA
Daily dornase alfa (DA) therapy in the DA Study
他の：Daily dornase alfa (DA)
Daily dornase alfa (DA) during the 52-week study period.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠：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.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Nicole Hamblett

協力者

Cystic Fibrosis Foundation

捜査官

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月15日

一次修了 (推定)

2030年2月28日

研究の完了 (推定)

2030年2月28日

試験登録日

最初に提出

2026年7月6日

QC基準を満たした最初の提出物

2026年7月6日

最初の投稿 (実際)

2026年7月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月10日

QC基準を満たした最後の更新が送信されました

2026年7月6日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • REACT-IP-25

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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