CFDB - Cystic Fibrosis DataBase

primary studies published RCT

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

Study design (if review, criteria of inclusion for studies)

Randomized, single-center, open-label, cross-over trial


Forty pediatric CF patients (8-17 years old) with stable disease


Patients randomized 1:1 into two groups: with or without Simeox(®).

Outcome measures

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.

Main results

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.

Authors' conclusions

Simeox(®) may improve drainage of the airways in children with clinically stable CF and could be an option in chronic treatment of the disease.

Keywords: Child; non pharmacological intervention - devices OR physiotherapy; Respiratory Tract Diseases; Airway clearance technique; Chest physiotherapy; Drainage;