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Could modern CF drugs make daily inhaled treatments obsolete?

NCT ID NCT07696338

Disease control Sponsor: Nicole Hamblett Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial investigates whether children and teens with cystic fibrosis who are already taking highly effective modulator therapy can safely use inhaled airway clearance treatments only when they have a respiratory illness, instead of every day. Participants stop their usual daily hypertonic saline or dornase alfa for a short run-in period, then are randomly assigned to either daily use or as-needed use for one year. The study measures lung function to see if both approaches keep lungs equally healthy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hypertonic saline and dornase alfa
What this could lead to
If successful, this could show that daily inhaled treatments are no longer needed for many children with cystic fibrosis who take modern modulators, reducing treatment burden.
What could go wrong
This is a mid-sized trial in children with mild lung disease; results may not apply to those with more severe disease. The study may also find that as-needed use leads to worse lung function over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 405 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis (CF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    39 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • CF Centre BC Children's Hospital (Vancouver, Canada)

    Vancouver, British Columbia, V6H3V4, Canada

  • CF Centre Hospital for Sick Children (Toronto, ON)

    Toronto, Ontario, M5G1X8, Canada

  • CHOC Children's Hospital

    Orange, California, 92868, United States

  • Children's Healthcare of Atlanta and Emory University

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's Mercy Kansas City

    Kansas City, Missouri, 64108, United States

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • John Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Oregon Health & Sciences University

    Portland, Oregon, 97239, United States

  • Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics

    Spokane, Washington, 99204, United States

  • Queen Elizabeth II Hospital Halifax Adult CF Centre

    Halifax, Nova Scotia, Canada

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Stanford University Medical Center

    Palo Alto, California, 94025, United States

  • The Children's Hospital Alabama, University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • The Minnesota Cystic Fibrosis Center

    Minneapolis, Minnesota, 55455, United States

  • Tucson Cystic Fibrosis Center

    Tucson, Arizona, 85724, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan, Michigan Medicine

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • University of Rochester Medical Center Strong Memorial

    Rochester, New York, 14642, United States

  • University of Texas Southwestern / Children's Health

    Dallas, Texas, 75207, United States

  • University of Virginia

    Charlottesville, Virginia, 22904, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

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