Skip to main content
OpenTrials
Completed

NCT Number: NCT04010253

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simeox

Device

Instrumental airway clearance by the medical device SIMEOX

Autogenic drainage

Other

Manual aiway clearance by autogenic drainage

Primary outcomes

  1. Low frequency resistance R5

    Time frame: 1 month

    Comparison of variations V4 and V8 sessions (pre and post airway clearance session)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: MUCOSIM

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 8, 2019
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.