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Could a Pulsed-Air device revolutionize mucus clearance for bronchiectasis?

NCT ID NCT06237348

Symptom relief Sponsor: Physio-Assist 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a device called Simeox, which uses pulsed air to help loosen and clear mucus from the airways, can improve lung function and quality of life in people with bronchiectasis who produce excess mucus. About 50 adults with the condition will use either Simeox or standard chest physiotherapy at home for two months. Researchers will track how often participants use the device, their symptoms, and any side effects to see if this technology is a practical and beneficial option.

What this could mean

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

Active substance
Simeox, a device that uses pulsed air to help clear mucus from the airways, compared with usual chest physiotherapy
What this could lead to
If it works, Simeox could offer a more effective and convenient way for people with bronchiectasis to clear mucus at home, potentially improving breathing and quality of life.
What could go wrong
This is a small pilot study, so results may not be conclusive. The device may not prove more effective than standard physiotherapy, and individual responses can vary.

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

50 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Patient with confirmed diagnosis of bronchiectasis confirmed by High Resolution Computed Tomography (HRCT): idiopathic, post-infective, systemic disease, ABPA, asthma, COPD, PCD * Overproduction of mucus (ie: estimated bronchorrhea \>10mL/day). * Pulmonary exacerbation (in- or outpatients) * Age \> 18 years old * Patient able to understand the study and to perform the 2-month follow up visit Exclusion Criteria: * Pneumothorax/pneumo-mediastinum in the six months prior hospitalization * Recent episode of severe haemoptysis * Unstable severe cardiac disease or hemodynamic instability * Cystic fibrosis or COPD as dominant diagnosis * Patient on lung transplant list * Severe lung injuries * Recent lung surgery * Inhalation support (continuous ventilatory support) * Tracheostomy * Uncontrolled GERD * Any contraindication to an instrumental bronchial clearance technique (up to the investigator) * Inability to perform PFT or 6MWT * Patient not available or wishing to move to a different region within 2 months of inclusion * Patient considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures. * Patient currently participating or having participated within one month prior to inclusion in a clinical intervention research trial that may impact the study, the impact of which is up to the investigator

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

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

Chronic mucus hypersecretion Non-cystic fibrosis bronchiectasis

Contacts and locations

Locations

  • Jagiellonian University Medical College

    Krakow, 30-688, Poland

  • N. Barlicki University Hospital No 1

    Lodz, 90-153, Poland

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