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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010253
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: SIMEOX Other: Autogenic drainage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Low frequency resistance R5 [ Time Frame: 1 month ]
    Comparison of variations V4 and V8 sessions (pre and post airway clearance session)


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010253


Contacts
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Contact: Jacqueline DELRIEU, PhD 0156814060 delrieu@antadir.com

Locations
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France
CH Amiens Recruiting
Amiens, France
Contact: Claire POULET, MD         
Hôpital la Bocage CHRU de Dijon Recruiting
Dijon, France
Contact: Guillaume BELTRAMO, MD         
CHRU Lille - Hopital Calmette Recruiting
Lille, France
Contact: Thierry PEREZ, MD       thierry.perez@chru-lille.fr   
GH Sud - Hospices Civils de Lyon Suspended
Lyon, France
CH Nice Recruiting
Nice, France
Contact: Sylvie LEROY, MD         
Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS Recruiting
Roscoff, France
Contact: Thomas ROPARS, MD         
CHU de Rouen Recruiting
Rouen, France
Contact: Stephane DOMINIQUE, MD         
Hopital Larrey Recruiting
Toulouse, France
Contact: Marlène MURRIS-ESPIN, MD         
Sponsors and Collaborators
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Investigators
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Principal Investigator: Thierry PEREZ, MD CHRU Lille
More Information
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Responsible Party: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier: NCT04010253    
Other Study ID Numbers: 2019-A00622-55
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche:
Cystic Fibrosis
Physiotherapy
Drainage
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases