Bronchiectasis AdultFISIOBRONCHINCT06801327
Comparison Between Conventional Respiratory Physiotherapy and the Simeox Device in Patients With Bronchiectasis
A study testing Simeox in people with Bronchiectasis Adult, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Simeox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vittoria Comellini, MD contact
Italy1 site, 1 recruiting
- Recruiting
Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, Bologna, 40138
Stefano Nava, MD, stefano.nava@aosp.bo.it
Vittoria Comellini, MD, vittoria.comellini@aosp.bo.it
About this study
Official title: Comparison Between Different Respiratory Physiotherapy Techniques in Patients With Bronchiectasis. Conventional Therapy Versus Simeox: a Single-center, Randomized, Controlled, Cross-over Study
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.
Read the detailed description
Single-center, prospective, open-label, 2x2 randomized crossover study. It is planned to consecutively enroll all outpatient patients who attend the bronchiectasis clinic of the Pneumology and Respiratory Intensive Care Unit of the IRCCS, University Hospital of Bologna, Policlinico S. Orsola. The study has a 2x2 crossover design for superiority. Each enrolled patient will undergo two treatment periods, each lasting 4 weeks. Patients randomized to Group A will undergo the first treatment with conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to current clinical-assistance practice at our clinic), while patients randomized to Group B will start treatment with the Simeox® device.
At the end of the first 4 weeks, the treatment will be interrupted, and a 1-week wash-out period will be observed. Based on what is commonly observed in clinical practice, it is believed that 1 week of wash-out is adequate time for mucus to re-accumulate in the airways and restore the baseline conditions necessary for the crossover, while also avoiding the risk of adverse events due to mucus accumulation. At the end of the wash-out week, the second phase of the study will begin, also lasting 4 weeks, with a treatment switch: Group A patients will use the Simeox® device, and Group B patients will undergo conventional respiratory physiotherapy.
Randomization will be conducted with a 1:1 ratio without stratification by the statisticians of the Research and Innovation Unit of the IRCCS AOUBO using statistical software. The randomization list will be entered into the study's eCRF, created with REDCap, and will be consulted by the investigators at each new enrollment. Treatment arm assignment will be performed at V1.
If the enrolled patients are already undergoing respiratory physiotherapy, they will be subjected to a 1-week wash-out period before starting the study, during which respiratory physiotherapy will be suspended. The Investigators will not include patients with cystic fibrosis (CF) in the study, as the production of bronchial secretions in this group of patients is substantial. In patients with bronchiectasis not due to CF, however, secretion production is generally much more modest, and, as done in other studies, a short wash-out period does not significantly increase risks for these patients. For greater caution, the study will only be proposed to patients in a stable phase (absence of ongoing exacerbations) and with sputum production < 200 mL/day (comparable to 1 plastic cup). These are the criteria by which, in clinical judgment, "non-strongly secretive" patients are identified. During the wash-out period, patients will be invited to contact us immediately if sputum production exceeds 200 mL/day, in which case the investigators will exclude the patient from the study and arrange a short-term visit.
- Conditions
- Bronchiectasis Adult
- Being tested
- Simeox
- Keywords
- Bronchiectasis, Respiratory physioterapy, Simeox, Conventional respiratory physioterapy
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimeoxDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Simeox |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
RR: Breath/Minutes
Measured: V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of blood oxygen
SpO2 (%)
Measured: At visits V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of hearth rate
HR (bpm)
Measured: At visits V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of blood pressure
Diastolic BP (mmHg) and Sistolic BP (mmHg)
Measured: At visits V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of spirometric values.
FEV1 (L), FVC (L), TLC (L) measured by Spirometry.
Measured: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Six-minute walk test (6MWT)
Distance covered and vital parameters such as SpO2, heart rate, and respiratory rate at the beginning, at the end, and after recovery from exercise measured by pulse oximeter and calculation of distance walked.
Measured: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Measurement of adverse events
Assessed in terms of the development of adverse events and their severity. Occurrence of adverse events: Adverse events reported by subjects.
Measured: V1 (Baseline,) Visit 2 (Day 7), Visit 3 (Week 5), Visit 4 (Week 6), Visit 5 (Week 10)
Tolerability and patient comfort
will be evaluated using a visual analog scale with a score from 0 to 10, with the latter representing the maximum comfort reported by the patient; measurements will be taken at the end of each of the study's scheduled sessions.
Measured: Visit 3 (Week 5), Visit 5 (Week 10)
Degree of dyspnea
Will be assessed using the modified Medical Research Council (mMRC) scale from 0 to 4, with the latter representing the most severe degree of dyspnea. This measurment will be taken the end of each physiotherapy session scheduled in the study.
Measured: Visit 3 (Week 5), Visit 5 (Week 10)
Volume of sputum (mL)
Recorded during the four weeks of treatment with each device using data reported in the "sputum diary"
Measured: Visit 3 (Week 5), Visit 5 (Week 10)
Quality of Sputum
Measured according Murray sputum colour chart stratifies patients according to the presence of mucous (M), muco-purulent (MP) or purulent (P) sputum, during the four weeks of treatment with each device using data reported in the "sputum diary".
Measured: Visit 3 (Week 5), Visit 5 (Week 10)
Number of exacerbations: Exacerbations reported by subjects.
Defined as a deterioration for at least 48 hours of three or more of the following key symptoms: cough, sputum volume or characteristics, sputum purulence, dyspnea and/or exercise intolerance, fatigue, malaise, and hemoptysis, associated with the clinician's belief that a change in treatment for bronchiectasis is necessary, occurring during the 4 weeks of treatment with each of the tested respiratory physiotherapy device
Measured: Visit 3 (Week 5), Visit 5 (Week 10)
Evaluation of Quality of Life for Bronchiectasis (QoLB)
Will be assessed using the Quality of Life for Bronchiectasis (QoLB) questionnaire. Scores range from 0 to 100, where higher scores indicate a better, higher quality of life (fewer symptoms, better function), and lower scores indicate a worse quality of life (more severe symptoms/limitations).
Measured: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Bronchiectasis Health Questionnaire (BHQ)
The Bronchiectasis Health Questionnaire (BHQ) measures health-related quality of life, scoring from 0 to 100, where higher scores indicate better health status and lower scores indicates poorer health status, higher symptom burden, and greater impact on daily life.
Measured: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Saint George Respiratory Questionnaire (SGRQ)
The St. George's Respiratory Questionnaire (SGRQ) measures health-related quality of life in patients with respiratory diseases, with total scores ranging from 0 to 100. Lower scores indicate better health (0 = no impairment), while higher scores signify greater impairment (100 = maximum impairment).
Measured: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Leicester Cough Questionnaire (LCQ)
The Leicester Cough Questionnaire (LCQ) measures the impact of chronic cough on physical, psychological, and social health, with a total score ranging from 3 to 21. Higher scores indicate better quality of life (less impact), while lower scores indicate severe impairment.
Measured: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Pittsburgh Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The global PSQI score ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Measured: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Dec 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, prospective, open-label, 2x2 randomized crossover study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Nava, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801327
- Sponsor's protocol ID
- FISIOBRONCHI
- Acronym
- FISIOBRONCHI
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38609097
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Respiratory Physiotherapy Techniques in Patients With Bronchiectasis. Conventional Therapy Versus Simeox: a Single-center, Randomized, Controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT06801327
- Acronym / sponsor ID
- FISIOBRONCHI / FISIOBRONCHI
- Conditions
- Bronchiectasis Adult
- Keywords
- Bronchiectasis, Respiratory physioterapy, Simeox, Conventional respiratory physioterapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Single-center, prospective, open-label, 2x2 randomized crossover study. It is planned to consecutively enroll all outpatient patients who attend the bronchiectasis clinic of the Pneumology and Respiratory Intensive Care Unit of the IRCCS, University Hospital of Bologna, Policlinico S. Orsola. The study has a 2x2 crossover design for superiority. Each enrolled patient will undergo two treatment periods, each lasting 4 weeks. Patients randomized to Group A will undergo the first treatment with conventional respiratory physiotherapy techniques (usually with Acapella, PEEP bottle, PEP mask, according to current clinical-assistance practice at our clinic), while patients randomized to Group B will start treatment with the Simeox® device.
At the end of the first 4 weeks, the treatment will be interrupted, and a 1-week wash-out period will be observed. Based on what is commonly observed in clinical practice, it is believed that 1 week of wash-out is adequate time for mucus to re-accumulate in the airways and restore the baseline conditions necessary for the crossover, while also avoiding the risk of adverse events due to mucus accumulation. At the end of the wash-out week, the second phase of the study will begin, also lasting 4 weeks, with a treatment switch: Group A patients will use the Simeox® device, and Group B patients will undergo conventional respiratory physiotherapy.
Randomization will be conducted with a 1:1 ratio without stratification by the statisticians of the Research and Innovation Unit of the IRCCS AOUBO using statistical software. The randomization list will be entered into the study's eCRF, created with REDCap, and will be consulted by the investigators at each new enrollment. Treatment arm assignment will be performed at V1.
If the enrolled patients are already undergoing respiratory physiotherapy, they will be subjected to a 1-week wash-out period before starting the study, during which respiratory physiotherapy will be suspended. The Investigators will not include patients with cystic fibrosis (CF) in the study, as the production of bronchial secretions in this group of patients is substantial. In patients with bronchiectasis not due to CF, however, secretion production is generally much more modest, and, as done in other studies, a short wash-out period does not significantly increase risks for these patients. For greater caution, the study will only be proposed to patients in a stable phase (absence of ongoing exacerbations) and with sputum production < 200 mL/day (comparable to 1 plastic cup). These are the criteria by which, in clinical judgment, "non-strongly secretive" patients are identified. During the wash-out period, patients will be invited to contact us immediately if sputum production exceeds 200 mL/day, in which case the investigators will exclude the patient from the study and arrange a short-term visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, prospective, open-label, 2x2 randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Device: SimeoxPatients 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 |
| Arm B | Other | Device: SimeoxPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimeoxThe 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. | Device | Arm A, Arm B |
Primary outcome
Measurement of respiratory mechanics (airway resistance)
Time frame: V1 (Baseline,) Visit 2 (Day 7), Visit 3 (Week 5), Visit 4 (Week 6), Visit 5 (Week 10)
Airway resistance at 5 Hz (R5) and airway resistance at 20 Hz (R20) measured in cmH2O/L/sec, using Forced Oscillometry Technique (FOT)
17 secondary outcomes
Evaluation of Respiratory Rate
Time frame: V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of blood oxygen
Time frame: At visits V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of hearth rate
Time frame: At visits V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of blood pressure
Time frame: At visits V1 (baseline), V3 (week 5), V5 (week 10)
Evaluation of spirometric values.
Time frame: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Six-minute walk test (6MWT)
Time frame: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Measurement of adverse events
Time frame: V1 (Baseline,) Visit 2 (Day 7), Visit 3 (Week 5), Visit 4 (Week 6), Visit 5 (Week 10)
Tolerability and patient comfort
Time frame: Visit 3 (Week 5), Visit 5 (Week 10)
Degree of dyspnea
Time frame: Visit 3 (Week 5), Visit 5 (Week 10)
Volume of sputum (mL)
Time frame: Visit 3 (Week 5), Visit 5 (Week 10)
Quality of Sputum
Time frame: Visit 3 (Week 5), Visit 5 (Week 10)
Number of exacerbations: Exacerbations reported by subjects.
Time frame: Visit 3 (Week 5), Visit 5 (Week 10)
Evaluation of Quality of Life for Bronchiectasis (QoLB)
Time frame: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Bronchiectasis Health Questionnaire (BHQ)
Time frame: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Saint George Respiratory Questionnaire (SGRQ)
Time frame: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Leicester Cough Questionnaire (LCQ)
Time frame: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Evaluation of Pittsburgh Sleep Quality Index
Time frame: V1 (Baseline), V3 (Week 5), V5 (Week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 38609097Spinou 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.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis Adult
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
RecruitingPhase 2
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingPhase 1
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Non-cystic Fibrosis Bronchiectasis, Bronchiectasis Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vittoria Comellini, MD contact
Stefano Nava, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simeox in people with Bronchiectasis Adult, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Nava, MD (+39 0512143253, stefano.nava@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of respiratory mechanics (airway resistance) (time frame: V1 (Baseline,) Visit 2 (Day 7), Visit 3 (Week 5), Visit 4 (Week 6), Visit 5 (Week 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06801327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.