Cystic FibrosisMUCOSIMNCT04010253
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
A study testing SIMEOX and Autogenic drainage in people with Cystic Fibrosis, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 8 sites in France.
Trial summary
The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- SIMEOX and Autogenic drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 8 sitesFrance
- Study dates
- 30 Sep 2019to 13 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cystic fibrosis confirmed
- Age ≥18 years
- 30% <FEV1 <70% predicted
- Presence of bronchial congestion reported by the patient or the investigator
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CH Amiens
Amiens
Hôpital la Bocage CHRU de Dijon
Dijon
CHRU Lille - Hopital Calmette
Lille
GH Sud - Hospices Civils de Lyon
Lyon
CH Nice
Nice
Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS
Roscoff
CHU de Rouen
Rouen
Hopital Larrey
Toulouse
About this study
Official title: Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients
The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.
- Conditions
- Cystic Fibrosis
- Being tested
- SIMEOX, Autogenic drainage
- Keywords
- Cystic Fibrosis, Physiotherapy, Drainage
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMEOXDevice
Instrumental airway clearance by the medical device SIMEOX
Autogenic drainageOther
Manual aiway clearance by autogenic drainage
| Study group | Role | What they receive |
|---|---|---|
| SIMEOX | Experimental | Not described Receives: Other: Autogenic drainage |
| Autogenic Drainage | Active comparator | Not described Receives: Device: SIMEOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low frequency resistance R5
Comparison of variations V4 and V8 sessions (pre and post airway clearance session)
Measured: 1 month
Secondary outcomes (4)
Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue
Measured: 1 month
Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations
Measured: 1 month
Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)
Measured: 1 month
Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start30 Sep 2019
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PEREZ, MD, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010253
- Sponsor's protocol ID
- 2019-A00622-55
- Acronym
- MUCOSIM
- Status last verified
- Mar 2026
- First submitted
- 3 Jul 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT04010253
- Acronym / sponsor ID
- MUCOSIM / 2019-A00622-55
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Physiotherapy, Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIMEOX | Experimental | Other: Autogenic drainage |
| Autogenic Drainage | Active comparator | Device: SIMEOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of cystic fibrosis confirmed
- Age ≥18 years
- 30% <FEV1 <70% predicted
- Presence of bronchial congestion reported by the patient or the investigator
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIMEOXInstrumental airway clearance by the medical device SIMEOX | Device | Autogenic Drainage |
| Autogenic drainageManual aiway clearance by autogenic drainage | Other | SIMEOX |
Primary outcome
Low frequency resistance R5
Time frame: 1 month
Comparison of variations V4 and V8 sessions (pre and post airway clearance session)
4 secondary outcomes
Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue
Time frame: 1 month
Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations
Time frame: 1 month
Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)
Time frame: 1 month
Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry PEREZ, MD principal investigator
CHRU LILLE
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMEOX and Autogenic drainage in people with Cystic Fibrosis, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low frequency resistance R5 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.