NCT04010253.

Study name	Impact of bronchial drainage by the medical device Simeox® on function and respiratory symptoms compared to manual autogenous drainage physiotherapy in adult cystic fibrosis patients
Methods	Randomised crossover trial
Participants	Recruitment: 42 participants Inclusion Criteria: Diagnosis of cystic fibrosis confirmed Age ≥18 years 30% <FEV1 <70% predicted Presence of bronchial congestion reported by the patient or the investigator Exclusion Criteria: Uncontrolled asthma Pneumothorax <6 weeks Recent severe hemoptysis <6 weeks Patient registered on the transplant list Exacerbation within 4 weeks (3 months if hospitalization) before screening Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non‐cystic fibrosis) conditions Patients unable to perform measurements of ROF, spirometry, plethysmography. Any contraindication to manual or instrumental physiotherapy. Pregnancy, breastfeeding. Patient under tutorship or curatorship No affiliation to the French social security
Interventions	Group 1: Simeox® device (Physio Assist, France)  Group 2: AD
Outcomes	Primary outcomes: Low frequency resistance R5. Comparison of variations V4 and V8 sessions (pre and post airway clearance session) with forced oscillation technique measured by TremoFlo™ C‐100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada).   Secondary outcomes:  Comparison of the impact of Simeox® bronchial drainage compared to AD on respiratory symptoms: dyspnea, congestion and fatigue. Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations. Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance). Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography).
Starting date	30 September 2019
Contact information	Jacqueline DELRIEU, PhD 0156814060 delrieu@antadir.com
Notes	Estimated study completion date: 31 January 2022

AD: autogenic drainage
CF: cystic fibrosis
FEF_25-75%: forced mid‐expiratory flow between 25% and 75% of forced vital capacity
FEV₁: forced expiratory volume in one second