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

NCT ID: NCT04010253

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2023-12-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIMEOX

Group Type: EXPERIMENTAL

Autogenic drainage

Intervention Type: OTHER

Manual aiway clearance by autogenic drainage

Autogenic Drainage

Group Type: ACTIVE_COMPARATOR

SIMEOX

Intervention Type: DEVICE

Instrumental airway clearance by the medical device SIMEOX

Interventions

SIMEOX

Instrumental airway clearance by the medical device SIMEOX

Intervention Type: DEVICE

Autogenic drainage

Manual aiway clearance by autogenic drainage

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry PEREZ, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU LILLE

Locations

CH Amiens

Amiens, , France

Site Status: RECRUITING

Hôpital la Bocage CHRU de Dijon

Dijon, , France

Site Status: RECRUITING

CHRU Lille - Hopital Calmette

Lille, , France

Site Status: RECRUITING

GH Sud - Hospices Civils de Lyon

Lyon, , France

Site Status: SUSPENDED

CH Nice

Nice, , France

Site Status: RECRUITING

Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS

Roscoff, , France

Site Status: RECRUITING

CHU de Rouen

Rouen, , France

Site Status: RECRUITING

Hopital Larrey

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jacqueline DELRIEU, PhD

Role: CONTACT

delrieu@antadir.com

0156814060

Facility Contacts

Claire POULET, MD

Role: primary

Guillaume BELTRAMO, MD

Role: primary

Thierry PEREZ, MD

Role: primary

thierry.perez@chru-lille.fr

Sylvie LEROY, MD

Role: primary

Thomas ROPARS, MD

Role: primary

Stephane DOMINIQUE, MD

Role: primary

Marlène MURRIS-ESPIN, MD

Role: primary

Other Identifiers

2019-A00622-55

Identifier Type: -

Identifier Source: org_study_id