Clinical trial NCT06237348: Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH
Official title: Airway Clearance Therapy With Simeox Technology in Non-Cystic Fibrosis Bronchiectasis Patients With Chronic Mucus Hypersecretion - A Multicenter Randomized Controlled Trial Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-cystic Fibrosis Bronchiectasis
Chronic Mucus Hypersecretion
Keywords: NCFB
CMH
Simeox
Airway clearance
ACT
Bronchiectasis
Telecare
Lead sponsor: Physio-Assist
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Lodz
name: University Hospital in Krakow
First posted: 2024-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open-label, parallel, Multicenter Randomized controlled trial,
Primary purpose: TREATMENT

Brief summary: This pilot RCT will assess benefits of Simeox technology on lung function, respiratory symptoms, health-related quality of life, subjective efficiency, device adherence at home, Patient satisfaction, tolerance, safety, and telecare feasibility.

Detailed description: Non-cystic fibrosis bronchiectasis (NCFB) is a chronic respiratory disease with multiple etiologies characterized by an irreversible dilatation of bronchi and an impair mucociliary clearance. These alterations cause sticky mucus retention and leads to recurrent infections and chronic bronchial inflammations. Chest physiotherapy is one of the cornerstones of the management of NCFB patients, particularly to facilitate airway clearance. In NCFB patients with chronic mucus hypersecretion (CMH), it is recommended that airway clearance sessions be carried out daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy for patients can be limited due to several causes: geographical, time or healthcare professional availability constraints. In addition, few healthcare professionals are trained for bronchial drainage especially with airway clearance devices.

SIMEOX® (Physio-Assist, France) is an innovative medical device (CE medical mark) for mucus clearance. The device is connected to patient mouth with an expiratory kit circuit. When the patient starts up the device during exhalation only, SIMEOX® disseminates a vibratory pneumatic signal in the bronchi that liquefies mucus and transports it from distal to central airways for sputum expectoration. After device training with respiratory physiotherapist, patients can be treated at hospital and use SIMEOX® in autonomy at home. Device training and patient follow-up can be performed also remotely with telecare with similar efficiency than face to face visits with health care professionals.

The main objective of this Pilot study is to evaluate the effects of mid-term use of SIMEOX® in autonomy at home for 2 months in NCFB patients with CMH and pulmonary exacerbation (in- or outpatients) in comparison to standard of care.

Eligibility criteria: Inclusion Criteria:

* Patient with confirmed diagnosis of bronchiectasis confirmed by High Resolution Computed Tomography (HRCT): idiopathic, post-infective, systemic disease, ABPA, asthma, COPD, PCD
* Overproduction of mucus (ie: estimated bronchorrhea \>10mL/day).
* Pulmonary exacerbation (in- or outpatients)
* Age \> 18 years old
* Patient able to understand the study and to perform the 2-month follow up visit

Exclusion Criteria:

* Pneumothorax/pneumo-mediastinum in the six months prior hospitalization
* Recent episode of severe haemoptysis
* Unstable severe cardiac disease or hemodynamic instability
* Cystic fibrosis or COPD as dominant diagnosis
* Patient on lung transplant list
* Severe lung injuries
* Recent lung surgery
* Inhalation support (continuous ventilatory support)
* Tracheostomy
* Uncontrolled GERD
* Any contraindication to an instrumental bronchial clearance technique (up to the investigator)
* Inability to perform PFT or 6MWT
* Patient not available or wishing to move to a different region within 2 months of inclusion
* Patient considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures.
* Patient currently participating or having participated within one month prior to inclusion in a clinical intervention research trial that may impact the study, the impact of which is up to the investigator

Primary outcomes:
measure: To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up
timeFrame: 2 months
Secondary outcomes:
measure: To describe Simeox therapy settings (program selection) during follow-up
timeFrame: 2 months
measure: To describe Simeox therapy settings (intensity) during follow-up
timeFrame: 2 months
measure: To describe Simeox therapy settings (number of session) during follow-up
timeFrame: 2 months
measure: To describe Simeox therapy settings (session duration) during follow-up
timeFrame: 2 months
measure: To evaluate mucus quality with Simeox therapy during follow-up
timeFrame: 2 months
measure: To evaluate breathing quality with Simeox therapy during follow-up
timeFrame: 2 months
measure: To evaluate ease handling of the Simeox device during follow-up
timeFrame: 2 months
measure: To evaluate pain during Simeox therapy
timeFrame: 2 months
measure: To evaluate fatigue during Simeox therapy
timeFrame: 2 months
measure: To evaluate ease of use of Simeox device after 2 months of therapy
timeFrame: 2 months
measure: To evaluate patient preference between Simeox device and usual care after 2 months of therapy
timeFrame: 2 months
measure: To evaluate patient recommendation to others patients of Simeox device after 2 months of therapy
timeFrame: 2 months
measure: Evaluate the feasibility of telecare during follow-up
timeFrame: 2 months
measure: To evaluate the effect of Simeox on respiratory symptoms in NCFB patients after 2 months of therapy
timeFrame: 2 months
measure: To evaluate the effect of Simeox on the health-related quality of life of NCFB patients after 2 months of therapy
timeFrame: 2 months
measure: To evaluate the effect of Simeox on Forced Expiratory Volume at 1 seconde (FEV1) after 2 monts of therapy
timeFrame: 2 months
measure: To evaluate the effect of Simeox on Forced Vital Capacity (FVC) after 2 monts of therapy
timeFrame: 2 months
measure: To evaluate the effect of Simeox on Forced Expiratory Flow (FEF) at 25%, 50% and 75% of FVC after 2 monts of therapy
timeFrame: 2 months
measure: To evaluate the effect of Simeox on dyspnea after 2 monts of therapy
timeFrame: 2 months
measure: To evaluate the effect of Simeox on exercise capacity after 2 monts of therapy
timeFrame: 2 months
measure: To evaluate safety of Simeox
timeFrame: 2 months
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
city: Lodz
country: Poland
facility: N. Barlicki University Hospital No 1
Study officials:
affiliation: Medical University of Lodz
name: Wojciech PIOTROWSKI, MD, PhD
role: STUDY_DIRECTOR
References: