Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis
Key facts
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 1 Dec 2024
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Simeox
- Record updated
- 2 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Diagnosis of COPD or bronchial asthma interpreted as primary and predominant diseases compared to bronchiectasis
- 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)
- Presence of tracheostomy
- 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
Where in Italy
- Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di BolognaBologna, ItalyContact: Stefano Nava, MDTaking people
About the trial
What the trial wants to find out
Physiotherapy is a key treatment for patients with bronchiectasis. An evaluation of the parameters indicative of respiratory health in patients treated with two different respiratory physiotherapy techniques (conventional versus Simeox®) would be very useful in choosing physiotherapy treatments for bronchiectasis patients. A systematic review of the literature shows that there are no published studies evaluating the effectiveness of respiratory physiotherapy by analyzing the variation in resistance measured using the forced oscillation technique (FOT) in patients with bronchiectasis. The results of this study would add to those that have examined different physiotherapy techniques and could therefore contribute to the choice of the most appropriate technique for this category of patients.
Read full original descriptionShow less
The trial is being conducted to answer the question: "How do respiratory parameters vary during treatment with two different respiratory physiotherapy techniques: conventional respiratory physiotherapy or that performed using the Simeox device?" Secondary objectives include the measurement of various functional parameters, such as vital signs (heart rate, respiratory rate, blood oxygenation, blood pressure values) and spirometry values (FEV1, FVC, TLC). The onset of adverse events, the degree of patient tolerance and relief, and respiratory health will also be assessed through the administration of various questionnaires commonly used in clinical practice. Additionally, changes in the quantity of sputum produced will be measured.
The 2 groups in the trial
- Arm AOther group
Patients randomized to Group A will undergo the first treatment with conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to the standard clinical-assistance practice at our clinic and they will switch to Simeox for the second treatment
Treatment: Simeox
- Arm BOther group
Patients randomized to Group B will undergo the first treatment with Simeox, and they will switch to conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to the standard clinical-assistance practice at our clinicfor the second treatment
Treatment: Simeox
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison Between Different Respiratory Physiotherapy Techniques in Patients With Bronchiectasis. Conventional Therapy Versus Simeox: a Single-center, Randomized, Controlled, Cross-over Study
- Record updated
- 2 March 2026