Late Breaking Abstract - Effects of a new airway clearance technology in children with cystic fibrosis - A homecare randomized controlled trial

Abstract

Introduction: This trial aims to evaluate in children the effects of a new airway clearance technology (Simeox, Physio-Assist) added to optimal standard care (SC) including chest physiotherapy (CPT) at home.

Methods: 40 pediatric patients (8-17 years) with clinically stable CF were randomized 1:1 in a cross-over trial: SC with (device) or without (control) Simeox. All patients performed CPT x3/day + bronchodilators x2/day and were treated x2/day with Simeox in device group. After 1 month of therapy at home, patients switched on other study group for 1 additional month of therapy. Spirometry, body plethysmography (BP), Impulse oscillometry system (IOS), Lung Clearance Index (LCI), health-related quality of life (CFQ-R), side effects, tolerability, satisfaction were assessed during the study.

Results: Baseline data: F/M 22/18, 13±3 y, BMI 19±3 kg/cm², FEV₁ 91±18%, FVC 97±14%. No side effects occurred. IOS parameters did not change in both groups. Compared to baseline, LCI z-score remained stable in device group but worsened in control group (p=0.014). MEF75 z-score improved in device group versus control (+0.30, p=0.008), other spirometry and BP criteria did not change in both groups. Physical functioning domain score of CFQ-R was improved in device group only (+3.4 versus control, p=0.015), respiratory score was unchanged in both groups. No pain nor discomfort in 95% of patients, 78% felt no fatigue during session. 73% preferred Simeox to CPT and 95% recommended it to other patients.

Conclusions: These results suggest that Simeox may improve drainage of central and peripheral airways in children with clinically stable CF and could be an option in chronic treatment of CF.