Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis

Single-center, prospective, open-label, 2x2 randomized crossover study. It is planned to consecutively enroll all outpatient patients who attend the bronchiectasis clinic of the Pneumology and Respiratory Intensive Care Unit of the IRCCS, University Hospital of Bologna, Policlinico S. Orsola. The study has a 2x2 crossover design for superiority. Each enrolled patient will undergo two treatment periods, each lasting 4 weeks. Patients randomized to Group A will undergo the first treatment with conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to current clinical-assistance practice at our clinic), while patients randomized to Group B will start treatment with the Simeox® device.

At the end of the first 4 weeks, the treatment will be interrupted, and a 1-week wash-out period will be observed. Based on what is commonly observed in clinical practice, it is believed that 1 week of wash-out is adequate time for mucus to re-accumulate in the airways and restore the baseline conditions necessary for the crossover, while also avoiding the risk of adverse events due to mucus accumulation. At the end of the wash-out week, the second phase of the study will begin, also lasting 4 weeks, with a treatment switch: Group A patients will use the Simeox® device, and Group B patients will undergo conventional respiratory physiotherapy.

Randomization will be conducted with a 1:1 ratio without stratification by the statisticians of the Research and Innovation Unit of the IRCCS AOUBO using statistical software. The randomization list will be entered into the study's eCRF, created with REDCap, and will be consulted by the investigators at each new enrollment. Treatment arm assignment will be performed at V1.

If the enrolled patients are already undergoing respiratory physiotherapy, they will be subjected to a 1-week wash-out period before starting the study, during which respiratory physiotherapy will be suspended. The Investigators will not include patients with cystic fibrosis (CF) in the study, as the production of bronchial secretions in this group of patients is substantial. In patients with bronchiectasis not due to CF, however, secretion production is generally much more modest, and, as done in other studies, a short wash-out period does not significantly increase risks for these patients. For greater caution, the study will only be proposed to patients in a stable phase (absence of ongoing exacerbations) and with sputum production < 200 mL/day (comparable to 1 plastic cup). These are the criteria by which, in clinical judgment, "non-strongly secretive" patients are identified. During the wash-out period, patients will be invited to contact us immediately if sputum production exceeds 200 mL/day, in which case the investigators will exclude the patient from the study and arrange a short-term visit.

Inclusion criteria

• Patients with a diagnosis of bronchiectasis not due to cystic fibrosis who are not hospitalized.
• Age ≥ 18 years.
• Evidence of bronchiectasis in at least one lung lobe from a chest CT scan performed within the 10 years prior to enrollment.
• Absence of exacerbations in the 28 days preceding enrollment.
• Sputum producers with volumes less than or equal to 200 mL/day.
• Under treatment with optimized standard therapy for bronchiectasis that has been stable for at least one year, with no changes in the 28 days prior to enrollment.
• Eligible for and/or already undergoing respiratory physiotherapy.
• Signed informed consent.

Exclusion criteria

• Diagnosis of COPD or bronchial asthma interpreted as primary and predominant diseases compared to bronchiectasis.
• Presence of tracheostomy.
• History of significant hemoptysis (≥300 mL of blood) or requiring embolization or blood transfusions in the 4 weeks preceding enrollment.
• Hemodynamic instability (mean arterial pressure < 65 mmHg, heart rate > 110 bpm).
• Undrained pneumothorax (evident on chest X-ray, deemed not worthy of pleural drainage according to standard clinical-assistance pathways and thus subjected to follow-up).
• Women who are pregnant or breastfeeding.