Comparing two types of respiratory physiotherapy for bronchiectasis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.