Efficacy of the Simeox ® Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial

Cystic fibrosis (CF) patients require regular airway clearance therapy (ACT). The aim of this study was to evaluate homecare therapeutic effects of a new ACT (Simeox ) added to the optimal standard of care, including home chest physiotherapy, in the treatment of clinically stable children. Forty ped...

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Published in:Children (Basel) 2023-01, Vol.10 (2), p.204
Main Authors: Sands, Dorota, Walicka-Serzysko, Katarzyna, Milczewska, Justyna, Postek, Magdalena, Jeneralska, Natalia, Cichocka, Aleksandra, Siedlecka, Ewa, Borawska-Kowalczyk, Urszula, Morin, Laurent
Format: Article
Language:English
Subjects:
Airway management
Care and treatment
chest physiotherapy
Clinical trials
Cystic fibrosis
Home care
homecare therapy
Intervention
Medical equipment
Methods
Pathogens
Patients
Pediatrics
Physical therapy
Physiological apparatus
pulmonary function test
Quality of life
Respiratory diseases
Simeox
Spirometry
Testing
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Summary:Cystic fibrosis (CF) patients require regular airway clearance therapy (ACT). The aim of this study was to evaluate homecare therapeutic effects of a new ACT (Simeox ) added to the optimal standard of care, including home chest physiotherapy, in the treatment of clinically stable children. Forty pediatric CF patients (8-17 years old) with stable disease were randomized 1:1 in a single-center, prospective, open-label, cross-over trial into two groups: with or without Simeox . Lung function (impulse oscillometry, spirometry, body plethysmography, multi-breath nitrogen washout) results, health-related quality of life, and safety were assessed during the study after 1 month of therapy at home. A significant decrease in proximal airway obstruction (as supported by improvement in airway resistance at 20 Hz (R20Hz) and maximum expiratory flow at 75% of FVC (MEF75)) compared to the control group was observed after 1 month of therapy with the device. Lung-clearance index was stable in the study group, while it worsened in the control group. In addition, the device group demonstrated a significant increase in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) physical score. No side effects were identified during the study. Simeox may improve drainage of the airways in children with clinically stable CF and could be an option in chronic treatment of the disease.
ISSN:2227-9067
2227-9067
DOI:10.3390/children10020204