Airway clearance management in people with bronchiectasis: data from the European Bronchiectasis Registry (EMBARC).
Arietta Spinou, Beatriz Hererro-Cortina, Stefano Aliberti...
https://pubmed.ncbi.nlm.nih.gov/38609097Actively 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
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Approximately 9 weeks (two 4-week treatments with a 1-week wash-out)
Participants undergo two treatment periods in a randomized crossover design. One period involves conventional respiratory physiotherapy techniques, and the other uses the Simeox device. Each treatment period lasts 4 weeks with a 1-week wash-out period in between.
5 visits: baseline (enrollment), Day 7, Week 5, Week 6 (after wash-out), and Week 10
Trial Site Locations
Total: 1 location
1
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
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Research Team
S
Stefano Nava, MD
V
Vittoria Comellini, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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