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Breathing training may ease childhood Asthma—A trial tests it

NCT ID NCT05945355

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study looks at whether inspiratory muscle training—exercises that strengthen breathing muscles—can improve asthma in children aged 6 to 17 with moderate to severe asthma. It compares two training intensities against a sham (inactive) device over 8 weeks. The trial also examines how obesity affects asthma and breathing muscle function, aiming to find better ways to manage the condition.

What this could mean

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

Active substance
Inspiratory muscle training using a PrO2 device at low or high intensity, compared to a sham device
What this could lead to
If effective, this could offer a drug-free way to ease asthma symptoms and improve breathing in children, especially those with obesity.
What could go wrong
This is a small, early-stage trial, and the training may not improve asthma control. The sham comparison helps, but results may not apply to all children.

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 76 people

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

Started

Aug 2024

Expected to finish

Oct 2027

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

6 to 17 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: * 6-17 years of age * Documented clinician-diagnosed asthma * Currently requiring 2 or more controller prescriptions to treat disease (i.e. moderate to severe persistent disease) * Either obese (≥95th percentile BMI and less than 170% of the 95th CDC percentile) or have a normal BMI (BMI 5th to 84th CDC percentile) Exclusion Criteria: * ACT (asthma control test) score \<17 * Ever intubated for asthma * FEV1 \< 50% of predicted at enrollment * Currently pregnant * Legal guardian unable to consent in English or Spanish * Any major chronic illness that, in the opinion of the PI, would interfere with participation * Younger than 6 years of age

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Conditions

The condition(s) this trial relates to.

childhood onset asthma Obesity obesity disorder Pediatric Obesity

As listed by the trial registrant

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

Asthma in children Obesity Pediatric asthma Pediatric obesity

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Duke Health Center Creekstone

    RECRUITING

    Durham, North Carolina, 27703, United States

  • Duke Healthy Lifestyles Clinic

    RECRUITING

    Durham, North Carolina, 27704, United States

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