What is this study trying to find out about bronchiectasis?

This study is comparing two respiratory physiotherapy methods—conventional techniques and the Simeox device—to see how they affect breathing and airway resistance in bronchiectasis patients. Researchers want to find which approach might better improve lung function and patient comfort. The study is sponsored by the IRCCS Azienda Ospedaliero-Universitaria di Bologna.

Who may be eligible for this bronchiectasis clinical trial?

Adults aged 18 years or older with bronchiectasis not caused by cystic fibrosis may be eligible. Participants should be stable without recent flare-ups and produce less than or equal to 200 mL of sputum daily. Both men and women can join, but pregnant or breastfeeding women are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this bronchiectasis clinical trial?

Study-related care, including the physiotherapy treatments and all trial visits, is provided at no cost. However, personal travel expenses or other related costs may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06801327

Comparison Between Conventional Respiratory Physiotherapy and Simeox Device in Patients With Bronchiectasis A Single-center, Randomized, Controlled, Cross-over Study

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-03-02

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating respiratory health in adults with bronchiectasis by comparing two types of respiratory physiotherapy conventional techniques and a device called Simeox. This study aims to understand how these methods affect airway resistance and other breathing-related measures. It addresses a gap in knowledge, as no prior studies have used forced oscillation technique FOT to assess these treatments in bronchiectasis patients. The study also monitors patient comfort, sputum production, and overall respiratory health through questionnaires and functional tests. This is a single-center, open-label, randomized crossover study where participants receive both types of physiotherapy in different sequences. Each treatment period lasts 4 weeks and is separated by a 1-week wash-out phase to allow mucus to return to baseline levels. Group A starts with conventional physiotherapy using devices like Acapella and PEP masks, then switches to Simeox, while Group B begins with Simeox and then switches to conventional therapy. Patients already receiving physiotherapy undergo a wash-out before starting the study. The Simeox device offers a unique approach by allowing calm exhalation and delivering vibrations to mobilize mucus without forced breathing. Participants will attend visits at baseline, day 7, week 5, week 6, and week 10 to measure airway resistance, vital signs heart rate, respiratory rate, oxygen levels, blood pressure, spirometry, and walking capacity. Adverse events, patient tolerance, sputum amount and quality, dyspnea level, and quality of life will be assessed using common questionnaires. The study lasts about 10 weeks, including treatment and wash-out periods, to comprehensively evaluate the effects and acceptability of both physiotherapy techniques in bronchiectasis patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients diagnosed with bronchiectasis not caused by cystic fibrosis who are not hospitalized
Age 18 years or older
Evidence of bronchiectasis in at least one lung lobe from a chest CT scan within the past 10 years
No bronchiectasis exacerbations in the 28 days before enrollment
Sputum production of 200 mL per day or less
Stable optimized standard therapy for bronchiectasis for at least one year, with no changes in the 28 days before enrollment
Eligible for or already undergoing respiratory physiotherapy
Signed informed consent

You will not qualify if you...

Diagnosis of COPD or bronchial asthma as the primary disease over bronchiectasis
Presence of tracheostomy
Significant hemoptysis (≥300 mL blood) or requiring embolization or blood transfusions in the 4 weeks before enrollment
Hemodynamic instability (mean arterial pressure < 65 mmHg or heart rate > 110 bpm)
Undrained pneumothorax observed on chest X-ray
Women who are pregnant or breastfeeding

Research Team

Stefano Nava, MD

Vittoria Comellini, MD

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