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

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Status: Enrolling

Conditions: Cystic Fibrosis

Treatments: Device: SIMEOX; Other: Autogenic drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT04010253

2019-A00622-55

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

SIMEOX

Experimental group

Treatment:

Other: Autogenic drainage

Autogenic Drainage

Active Comparator group

Treatment:

Device: SIMEOX