Introduction

According to the 2018 standards of cares for Cystic fibrosis (CF), meticulous daily management of lung disease is essential to

prevent infection and preserve lung function in CF. However, daily chest physiotherapy may be a burden for patients and relatives

and prescription of a suitable airway clearance technique (ACT) should therefore be tailored to patient preference.

SIMETOL study aims to assess through a multidisciplinary approach, the feasibility, safety and efficacy of Simeox (PhysioAssist,

France) in patients with stable chronic obstructive pulmonary disease and requiring airway secretion clearance.

Patients

Subset of adult CF patients, male or female, with stable lung function and FVC and/or FEV1 <85% of predicted and requiring a

hospitalization duration of 5 to 8 days for routine medical checkup including airway clearance therapy.

Patients were excluded if they had contraindication to chest physiotherapy, non-productive bronchial drainage session, required

more than 2 chest physiotherapy sessions per day, had lung transplant, >8 hours per day of mechanical ventilation, hemoptysis

or pneumothorax within last month, pan-drug-resistant bacteria, or were participating in another trial.

Clinical study

This prospective open monocentric crossover clinical trial was approved by a French National Ethic Committee (Comité de

Protection des Personnes Sud-Méditerranée 1) and authorized by the French National Competent Health Authority (ANSM).

All patients gave informed consent before any study procedure. The study was conducted in accordance with Good Clinical Practice

and the principles of the Declaration of Helsinki. The study was registered at ClinicalTrials.gov registry (NCT02061852).

The data presented below are derived from a statistical subgroup analysis of patients with Cystic Fibrosis (CF) recruited in the study.

Intervention

Patients were treated during hospitalization for 4 consecutive days (2 x 20-45 min session per day, one in the morning and one

in the afternoon) with their usual conventional chest physiotherapy (autogenic drainage, active cycle of breathing techniques,

forced expiration techniques, controlled coughing, airway clearance devices).

Simeox technology was introduced in the morning of Day 2 and 4 in replacement of usual chest physiotherapy session. As a

result, patient received usual physiotherapy alone on day 1 and 3 and combined physiotherapy techniques (usual and Simeox)

on day 2 and 4.

Side effects (excessive fatigue, dizziness due to hyperventilation, headache, cervical pain, nausea, sore throat), tolerability (fatigue,

pain, ventilatory adaptation) and usability of Simeox device was assessed during the study. 24h-wet sputum weight and pulse

oximetry (SpO2) before/after each session were compared between therapies.

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