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New breathing device aims to unclog lungs in bronchiectasis patients

NCT ID NCT07443124

Symptom relief Sponsor: Inogen Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study will test the Simeox 200, a device designed to help clear mucus from the lungs, in 35 adults with bronchiectasis who produce a lot of phlegm. Participants will use the device twice daily for two weeks, and researchers will measure how much mucus is cleared, along with changes in lung function and symptoms. The goal is to see if the device is a practical and effective option for daily airway clearance at home.

What this could mean

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

Active substance
Simeox 200 airway clearance device
What this could lead to
If successful, this device could offer a new way to help bronchiectasis patients clear mucus more easily at home, potentially reducing symptoms and improving daily life.
What could go wrong
This is a very small, early pilot study with only 35 people and no comparison group, so results may not apply broadly. The device may not work better than existing methods, and individual results 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

About 35 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

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 to 85 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: 1. Diagnosis of bronchiectasis confirmed by computed chest tomography (CT chest) performed within the prior 36 months 2. Persistent productive cough for which daily airway clearance therapy is prescribed. 3. Daily sputum production estimated at \> 1 tsp or 5 ml 4. Clinically stable on medical regimen with no pulmonary exacerbation in the past 4 weeks prior to study enrolment 5. Subject able to sign informed consent Exclusion Criteria: 1. Inability to cough forcefully and independently, as determined by the clinician 2. Ventilatory assistance with endotracheal tube, tracheostomy tube, or mask (not including nocturnal CPAP) 3. Neuromuscular disease with muscle respiratory weakness 4. Severe restrictive lung disease defined as Forced Vital Capacity (FVC) \<60% of predicted 5. Unstable cardiac disease (e.g. major cardiac arrhythmia, unstable heart failure, heart attack, unstable angina) 6. Hemodynamic instability, as determined by the clinician 7. Airway at risk for aspiration, as determined by the clinician 8. Uncontrolled gastroesophageal reflux disease (GERD) as determined by the clinician 9. Upper airway surgery in the prior 3 months 10. Cardiothoracic surgery, including esophageal surgery, in the prior 6 months 11. Anticipated hospitalization within the next 2 weeks 12. History of pneumothorax within the prior 6 months 13. History of haemoptysis treated with embolization within the prior 12 months 14. Inability to use airway clearance therapy as directed 15. Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol 16. Pregnant or lactating female

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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.

Bronchiectasis Mucus; plug

How to take part

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

  1. The places running it

    1 site. 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

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

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