Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04010253

Acronym

MUCOSIM

Enrollment

Registered

2019-07-08

Start date

2019-09-30

Completion date

2023-12-13

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis, Physiotherapy, Drainage

Brief 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. 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.

Interventions

DEVICESIMEOX

Instrumental airway clearance by the medical device SIMEOX

OTHERAutogenic drainage

Manual aiway clearance by autogenic drainage

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Low frequency resistance R5	1 month	Comparison of variations V4 and V8 sessions (pre and post airway clearance session)

Secondary

Measure	Time frame
Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue	1 month
Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations	1 month
Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)	1 month
Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)	1 month

Countries

France

Contacts

PRINCIPAL_INVESTIGATORThierry PEREZ, MD

CHRU LILLE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026