NCT06801327 Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis
| NCT ID | NCT06801327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Bronchiectasis Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-12-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. 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.
Eligibility Criteria
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.
Contact & Investigator
Stefano Nava, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06801327 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06801327 currently recruiting?
Yes, NCT06801327 is actively recruiting participants. Contact the research team at stefano.nava@aosp.bo.it for enrollment information.
Where is the NCT06801327 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06801327 clinical trial?
NCT06801327 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Stefano Nava, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 40 participants.