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

Cystic Fibrosis Clinical Trial

— MUCOSIM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010253
• Other study ID #: 2019-A00622-55
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Contact: Jacqueline DELRIEU, PhD
• Phone: 0156814060
• Email: delrieu[@]antadir.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• SIMEOX
Instrumental airway clearance by the medical device SIMEOX

Other:
• Autogenic drainage
Manual aiway clearance by autogenic drainage

Locations

Country	Name	City	State
France	CH Amiens	Amiens
France	Hôpital la Bocage CHRU de Dijon	Dijon
France	CHRU Lille - Hopital Calmette	Lille
France	GH Sud - Hospices Civils de Lyon	Lyon
France	CH Nice	Nice
France	Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS	Roscoff
France	CHU de Rouen	Rouen
France	Hopital Larrey	Toulouse

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low frequency resistance R5	Comparison of variations V4 and V8 sessions (pre and post airway clearance session)	1 month
Secondary	Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue		1 month
Secondary	Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations		1 month
Secondary	Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)		1 month
Secondary	Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)		1 month