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

NCT06801327 | Recruiting

• 1 other identifier: FISIOBRONCHI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis Adult

Keywords

Bronchiectasis; Respiratory physioterapy; Simeox; Conventional respiratory physioterapy

Outcome Measures

Primary Outcomes (1)

• Measurement of respiratory mechanics (airway resistance)

  Airway resistance at 5 Hz (R5) and airway resistance at 20 Hz (R20) measured in cmH2O/L/sec, using Forced Oscillometry Technique (FOT)

  V1 (Baseline,) Visit 2 (Day 7), Visit 3 (Week 5), Visit 4 (Week 6), Visit 5 (Week 10)

Secondary Outcomes (17)

• Evaluation of Respiratory Rate

  V1 (baseline), V3 (week 5), V5 (week 10)

• Evaluation of blood oxygen

  At visits V1 (baseline), V3 (week 5), V5 (week 10)

• Evaluation of hearth rate

  At visits V1 (baseline), V3 (week 5), V5 (week 10)

• Evaluation of blood pressure

  At visits V1 (baseline), V3 (week 5), V5 (week 10)

• Evaluation of spirometric values.

  V1 (Baseline), V3 (Week 5), V5 (Week 10)

Study Arms (2)

Arm A

OTHER

Patients randomized to Group A will undergo the first treatment with conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to the standard clinical-assistance practice at our clinic and they will switch to Simeox for the second treatment

Device: Simeox

Arm B

OTHER

Patients randomized to Group B will undergo the first treatment with Simeox, and they will switch to conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to the standard clinical-assistance practice at our clinicfor the second treatment

Device: Simeox

Interventions

Simeox DEVICE

The Investigators chose to evaluate this device for respiratory physiotherapy in our patients because it is the only one that offers innovative technology, as, unlike other commercially available devices, it does not require the patient to perform forced breathing. Instead, the patient can exhale calmly at tidal volume. This is expected to reduce the patient's effort and improve compliance with treatment. Furthermore, the vibratory signal with small, rapid, and sequential depressions within the airways could be more effective in mobilizing mucus from the airways, preventing collapse.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Related Publications (1)

• Spinou A, Hererro-Cortina B, Aliberti S, Goeminne PC, Polverino E, Dimakou K, Haworth CS, Loebinger MR, De Soyza A, Vendrell M, Burgel PR, McDonnell M, Sutharsan S, Skrgat S, Maiz-Carro L, Sibila O, Stolz D, Kauppi P, Bossios A, Hill AT, Clifton I, Crichton ML, Walker P, Menendez R, Borekci S, Obradovic D, Nowinski A, Amorim A, Torres A, Lorent N, Welte T, Blasi F, Jankovic Makek M, Shteinberg M, Boersma W, Elborn JS, Chalmers JD, Ringshausen FC; EMBARC Registry Collaborators. Airway clearance management in people with bronchiectasis: data from the European Bronchiectasis Registry (EMBARC). Eur Respir J. 2024 Jun 6;63(6):2301689. doi: 10.1183/13993003.01689-2023. Print 2024 Jun.

  PMID: 38609097 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Stefano Nava, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Nava, MD

CONTACT

+39 0512143253; stefano.nava@aosp.bo.it

Vittoria Comellini, MD

CONTACT

vittoria.comellini@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, open-label, 2x2 randomized crossover study

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 30, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)