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

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Autogenic drainage; Device: SIMEOX

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacqueline DELRIEU, PhD; Phone Number: 0156814060; Email: delrieu@antadir.com

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CH Amiens
    • Contact: Claire POULET, MD
  • Dijon, France
    • Recruiting
    • Hôpital la Bocage CHRU de Dijon
    • Contact: Guillaume BELTRAMO, MD
  • Lille, France
    • Recruiting
    • CHRU Lille - Hopital Calmette
    • Contact: Thierry Perez, MD; Email: thierry.perez@chru-lille.fr
  • Lyon, France
    • Suspended
    • GH Sud - Hospices Civils de Lyon
  • Nice, France
    • Recruiting
    • CH Nice
  • Roscoff, France
    • Recruiting
    • Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS
    • Contact: Thomas ROPARS, MD
  • Rouen, France
    • Recruiting
    • CHU de Rouen
  • Toulouse, France
    • Recruiting
    • Hopital Larrey
    • Contact: Marlène MURRIS-ESPIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SIMEOX	Other: Autogenic drainage; Manual aiway clearance by autogenic drainage
ACTIVE_COMPARATOR: Autogenic Drainage	Device: SIMEOX; Instrumental airway clearance by the medical device SIMEOX

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (ACTUAL): July 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Physiotherapy; Drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 2019-A00622-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No