Rethinking Early Airway Clearence Therapies

Conditions

• Cystic Fibrosis (CF)

Eligibility Criteria

Sex

ALL

Age

3 Years - 16 Years

Healthy Volunteers

Not accepted

Interventions

• As-needed hypertonic saline (HS) — OTHER
  As-needed hypertonic saline (HS) therapy during the 52-week study period.
• Twice daily hypertonic saline (HS) — OTHER
  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).
• As-needed dornase alfa (DA) — OTHER
  As-needed dornase alfa (DA) therapy during the 52-week study period.
• Daily dornase alfa (DA) — OTHER
  Daily dornase alfa (DA) during the 52-week study period.

Study Details

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.

Key Dates

First listed

Jul 10, 2026

Start date

Sep 15, 2026

Status verified

Jul 2026

Primary completion

Feb 28, 2030

Completion

Feb 28, 2030

Study Design

Enrollment

405 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: As-Needed HS
  As-needed hypertonic saline (HS) therapy in the HS Study
• Active Comparator: Daily HS
  Twice daily hypertonic saline (HS) therapy in the HS Study
• Experimental: As-Needed DA
  As-needed dornase alfa (DA) therapy in the DA Study
• Active Comparator: Daily DA
  Daily dornase alfa (DA) therapy in the DA Study

Primary Outcome Measure

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. [ Time Frame: 52 weeks ]

Central Contacts

• Rachael Buckingham
  206-884-7517
  [email protected]
• Anna Mead
  [email protected]

Locations (36)

Find similar trials in Birmingham, AL

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