Comparing two types of respiratory physiotherapy for bronchiectasis patients
Comparison Between Different Respiratory Physiotherapy Techniques in Patients With Bronchiectasis. Conventional Therapy Versus Simeox: a Single-center, Randomized, Controlled, Cross-over Study
This study is testing which of two types of breathing therapy works better for people with bronchiectasis to help improve their lung health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06801327 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different respiratory physiotherapy techniques in patients with bronchiectasis: conventional methods and the Simeox device. It employs a single-center, prospective, open-label, 2x2 randomized crossover design, where participants will undergo both treatment methods over two 4-week periods separated by a wash-out week. The study aims to assess variations in respiratory health parameters using the forced oscillation technique (FOT) to determine the most effective physiotherapy approach for bronchiectasis patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of bronchiectasis not due to cystic fibrosis, who are stable and undergoing optimized standard therapy.
Not a fit: Patients with COPD, bronchial asthma, or significant hemoptysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective physiotherapy technique for improving respiratory health in bronchiectasis patients.
How similar studies have performed: While there is limited published research specifically comparing these two techniques, the study aims to fill a gap in existing literature on respiratory physiotherapy for bronchiectasis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna, Bologna
- Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Nava, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Stefano Nava, MD
- Email: stefano.nava@aosp.bo.it
- Phone: +39 0512143253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.