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New device aims to clear lungs better in cystic fibrosis

NCT ID NCT04010253

Symptom relief Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a device called Simeox, which helps clear mucus from the lungs, against a standard manual breathing technique (autogenic drainage) in 31 adults with cystic fibrosis. The goal was to see which method better improves lung function and eases symptoms like cough and congestion. Researchers measured lung function before and after each session to compare the two approaches.

What this could mean

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

Active substance
Simeox device (airway clearance device)
What this could lead to
If it works, this could offer a more effective or easier way to clear mucus from the lungs in cystic fibrosis, potentially improving breathing and reducing symptoms.
What could go wrong
This is a small, completed study with only 31 participants, so results may not apply to everyone. The device may not work better than standard manual techniques.

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

31 people

The number who actually took part.

Started

Sep 2019

Finished

Dec 2023

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

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: * Diagnosis of cystic fibrosis confirmed * Age ≥18 years * 30% \<FEV1 \<70% predicted * Presence of bronchial congestion reported by the patient or the investigator Exclusion Criteria: * Uncontrolled asthma * Pneumothorax \<6 weeks * Recent severe hemoptysis \<6 weeks * Patient registered on the transplant list * Exacerbation within 4 weeks (3 months if hospitalization) before screening * Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions * Patients unable to perform measurements of ROF, spirometry, plethysmography. * Any contraindication to manual or instrumental physiotherapy. * Pregnancy, breastfeeding. * Patient under tutorship or curatorship * No affiliation to the French social security * Patient using Simeox at home * Patient under Trikafta for less than 6 weeks. * Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion

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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

Contacts and locations

Locations

  • CH Amiens

    Amiens, France

  • CH Nice

    Nice, France

  • CHRU Lille - Hopital Calmette

    Lille, France

  • CHU de Rouen

    Rouen, France

  • GH Sud - Hospices Civils de Lyon

    Lyon, France

  • Hopital Larrey

    Toulouse, France

  • Hôpital la Bocage CHRU de Dijon

    Dijon, France

  • Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS

    Roscoff, France

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