Chronic Obstructive Pulmonary Disease (COPD)SIMEO-RV COPDNCT07665931
Effect of Simeox® on Residual Volume in COPD Patients With Pulmonary Hyperinflation
A study testing Simeox in people with Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hyperinflation, run by Azienda Socio Sanitaria Territoriale di Lodi at 1 site in Italy.
Trial summary
Brief Summary People with severe chronic obstructive pulmonary disease (COPD) often have too much air trapped in their lungs (pulmonary hyperinflation). This makes it hard to breathe and reduces quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Hyperinflation
- What is being tested?
- Simeox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2026to 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
- Age ≥ 18 years
- Diagnosis of severe or very severe COPD (GOLD stage 3-4)
- Documented pulmonary hyperinflation defined by at least one of the following criteria measured by nitrogen wash-out (N₂ wash-out):
- Residual volume (RV) > 150% of predicted
- Functional residual capacity (FRC) > 130% of predicted
- Total lung capacity (TLC) > 120% of predicted
Show all 10Show fewer
- RV/TLC ratio > 40%
- Clinical stability (no exacerbations in the 3 weeks prior to enrollment)
- Patients for whom assessment of the effect of Simeox® on reduction of pulmonary hyperinflation is considered clinically appropriate, in the context of exploratory device use
- Written informed consent
Who cannot join
- Active or recent pneumothorax (< 6 weeks), predisposition to pneumothorax or pneumomediastinum, or known pleural fragility
- Active or recent gross haemoptysis (< 6 weeks) or active pulmonary haemorrhage
- Haemodynamic instability
- Unstable cardiovascular conditions, including:
- Recent myocardial infarction
- Unstable angina
Show all 18Show fewer
- Uncontrolled arrhythmias
- Unstable heart failure
- Recent cardiothoracic surgery (< 3 months), including oesophageal surgery
- Recent thoracic trauma or severe acute lung injury
- Continuous mechanical ventilation, active need for inspiratory assistance, or tracheostomy
- Neuromuscular diseases with respiratory muscle weakness
- Inspiratory muscle weakness precluding increased respiratory effort
- Oropharyngeal or oral muscle weakness
- Inability to cough effectively, forcefully and autonomously
- Severe restrictive lung disease (TLC < 60% of predicted)
- Airways at risk of aspiration (e.g. recent nasogastric tube feeding)
- Uncontrolled gastro-oesophageal reflux disease (GERD)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Lodi - Presidio Ospedaliero di Codogno
Codogno, Lombardy, 26845
Andrea Di Matteo, dr, +393387123135, andrea.dimatteo@asst-lodi.it
dimatteo.fisio@gmail.com
About this study
Official title: Prospective, Uncontrolled, Single-arm, Interventional Study With Pre-post Intervention Assessment on the Effect of the Simeox® Electro-medical Device on Residual Volume in Patients With COPD and Pulmonary Hyperinflation
Brief Summary People with severe chronic obstructive pulmonary disease (COPD) often have too much air trapped in their lungs (pulmonary hyperinflation). This makes it hard to breathe and reduces quality of life. This study tests whether a single session with a medical device called Simeox® can reduce the amount of air trapped in the lungs. Simeox® works by applying gentle intermittent negative pressure during exhalation to help air move out of the lungs more easily. Patients with severe or very severe COPD and documented hyperinflation will undergo lung function measurements before and immediately after a 20-minute Simeox® session. The main measurement is the change in residual volume (RV), which is the amount of air left in the lungs after a full exhalation. We will also measure changes in other lung volumes, breathlessness, and any side effects. This is a single-arm pilot study enrolling 23 patients at one center in Italy (ASST Lodi). The study is non-profit and has been approved by the Ethics Committee Comitato Etico Territoriale Lombardia 1 (CET Lombardia 1).
Read the detailed description
Detailed Description Pulmonary hyperinflation is a key pathophysiological feature of advanced chronic obstructive pulmonary disease (COPD), resulting from air trapping due to airflow obstruction and reduced elastic recoil. It is strongly associated with dyspnea, exercise intolerance, and impaired quality of life. Reducing residual volume (RV) is therefore a clinically meaningful therapeutic target in patients with severe and very severe COPD.
Simeox® is a CE-marked electro-medical device currently used in clinical practice for bronchial secretion drainage. It applies intermittent negative pressure at high frequency (6-12 Hertz, Hz) during the expiratory phase, with the aim of increasing expiratory flow velocity and promoting air mobilization. While the device is routinely used in patients with bronchial hypersecretion, its potential effect on static lung volumes in patients with hyperinflation - regardless of the presence of significant secretions - has not been systematically investigated.
This prospective, single-arm, non-controlled pilot study aims to explore the immediate effect of a single Simeox® session on RV in patients with severe or very severe COPD and documented pulmonary hyperinflation.
Study procedure:
Each participant undergoes baseline lung function assessment using spirometry and nitrogen wash-out (N₂ wash-out), followed by a single Simeox® treatment session lasting approximately 20 minutes (4 series of 10 tidal breathing cycles in a seated position, with rest breaks according to tolerance). During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure modulated to the maximum tolerated intensity. Lung function measurements are repeated immediately after the session (within 30 minutes).
Safety monitoring:
Respiratory rate, heart rate, and peripheral oxygen saturation (SpO₂) are monitored throughout the session. Adverse events are recorded and classified by type, severity, and relationship to the treatment. Tolerability is assessed through subjective patient rating and dyspnea score variation.
Statistical analysis:
Pre- and post-intervention comparisons will be performed using a paired t-test or Wilcoxon signed-rank test depending on data distribution (significance level p < 0.05). Sample size was calculated based on a clinically meaningful RV reduction of 0.40 L (standard deviation, SD: 0.60 L), yielding a minimum of 21 patients (80% power, α = 0.05), with 23 patients planned to account for dropouts.
This pilot study will provide the methodological basis for designing a future randomized controlled trial (RCT) with a larger sample and longer follow-up.
- Being tested
- Simeox
- Keywords
- COPD, Pulmonary Hyperinflation, Residual Volume, Air Trapping, Simeox, Intermittent Negative Pressure, airway Clearance, Lung Volumes, Nitrogen Washout, Spirometry, Dyspnea, Respiratory Physiotherapy, Pilot Study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimeoxDevice
Also called Intermittent Negative Pressure Device
Single treatment session of approximately 20 minutes with the Simeox® electro-medical device. The session consists of 4 series of 10 tidal breathing cycles performed in a seated position, with rest breaks according to patient tolerance. During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure (6-12 Hz), modulated to the maximum tolerated intensity. Treatment efficacy is monitored through visual indicators integrated into the device.
| Study group | Role | What they receive |
|---|---|---|
| Simeox Treatment | Experimental | All enrolled patients undergo a single session of treatment with the Simeox® device. Lung function is assessed before and immediately after the session. No control or comparator group is included. Receives: Device: Simeox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Residual Volume (RV)
Absolute change in residual volume (ΔRV, liters) measured by nitrogen wash-out (N₂ wash-out) before and immediately after a single Simeox® treatment session
Measured: Baseline and within 30 minutes after the end of the treatment session
Secondary outcomes (5)
Change in Functional Residual Capacity (FRC)
Absolute change in functional residual capacity (ΔFRC, liters) measured by nitrogen wash-out (N₂ wash-out) before and immediately after the treatment session
Measured: Baseline and within 30 minutes after the end of the treatment session
Change in Vital Capacity (VC)
Absolute change in vital capacity (ΔVC, liters) measured by spirometry before and immediately after the treatment session
Measured: Baseline and within 30 minutes after the end of the treatment session
Change in Dyspnea Score
Change in dyspnea assessed using the modified Borg CR10 scale (range 0-10; higher scores indicate greater dyspnea) before and immediately after the treatment session
Measured: Baseline and within 30 minutes after the end of the treatment session
Incidence of Adverse Events
Number and type of adverse events classified by severity (mild, moderate, severe) and relationship to the treatment (related, probably related, unrelated)
Measured: From the start of the treatment session up to 30 minutes after session completion
Treatment Tolerability
Tolerability assessed by subjective patient rating at the end of the session (tolerated / poorly tolerated / not tolerated) and by the need to interrupt or modify the session due to discomfort or adverse symptoms
Measured: From the start of the treatment session up to 30 minutes after session completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start5 May 2026
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Lodi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Di Matteo, Azienda Socio Sanitaria Territoriale di Lodi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665931
- Sponsor's protocol ID
- CET 100-2026
- Acronym
- SIMEO-RV COPD
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, given the exploratory and pilot nature of the study, the small sample size (23 patients), and the need to protect participant privacy in accordance with Italian and European data protection regulations (GDPR). Aggregate results will be made publicly available through publication in a peer-reviewed journal and/or presentation at scientific conferences within 12 months of study completion, as required by the approving Ethics Committee (CET Lombardia 1).
Publications
. Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Boca Raton: Chapman & Hall/CRC; 2008.
Hartman JE, Ten Hacken NH, Klooster K, Boezen HM, de Greef MH, Slebos DJ. The minimal important difference for residual volume in patients with severe emphysema. Eur Respir J. 2012 Nov;40(5):1137-41. doi: 10.1183/09031936.00219111. Epub 2012 Mar 22.
PubMed 22441742Fessler HE, Scharf SM, Permutt S. Improvement in spirometry following lung volume reduction surgery: application of a physiologic model. Am J Respir Crit Care Med. 2002 Jan 1;165(1):34-40. doi: 10.1164/ajrccm.165.1.2101149.
PubMed 11779727Hopkinson NS, Toma TP, Hansell DM, Goldstraw P, Moxham J, Geddes DM, Polkey MI. Effect of bronchoscopic lung volume reduction on dynamic hyperinflation and exercise in emphysema. Am J Respir Crit Care Med. 2005 Mar 1;171(5):453-60. doi: 10.1164/rccm.200407-961OC. Epub 2004 Dec 3.
PubMed 15579725Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
PubMed 16135736O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.
PubMed 17729066Garcia-Rio F, Lores V, Mediano O, Rojo B, Hernanz A, Lopez-Collazo E, Alvarez-Sala R. Daily physical activity in patients with chronic obstructive pulmonary disease is mainly associated with dynamic hyperinflation. Am J Respir Crit Care Med. 2009 Sep 15;180(6):506-12. doi: 10.1164/rccm.200812-1873OC. Epub 2009 Jun 19.
PubMed 19542481Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. doi: 10.2147/copd.2006.1.4.381.
PubMed 18044095Cooper CB. The connection between chronic obstructive pulmonary disease symptoms and hyperinflation and its impact on exercise and function. Am J Med. 2006 Oct;119(10 Suppl 1):21-31. doi: 10.1016/j.amjmed.2006.08.004.
PubMed 16996896Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2024.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Uncontrolled, Single-arm, Interventional Study With Pre-post Intervention Assessment on the Effect of the Simeox® Electro-medical Device on Residual Volume in Patients With COPD and Pulmonary Hyperinflation
- ClinicalTrials.gov ID
- NCT07665931
- Acronym / sponsor ID
- SIMEO-RV COPD / CET 100-2026
- Keywords
- COPD, Pulmonary Hyperinflation, Residual Volume, Air Trapping, Simeox, Intermittent Negative Pressure, airway Clearance, Lung Volumes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di LodiUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jun 2026 (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.
Brief Summary People with severe chronic obstructive pulmonary disease (COPD) often have too much air trapped in their lungs (pulmonary hyperinflation). This makes it hard to breathe and reduces quality of life. This study tests whether a single session with a medical device called Simeox® can reduce the amount of air trapped in the lungs. Simeox® works by applying gentle intermittent negative pressure during exhalation to help air move out of the lungs more easily. Patients with severe or very severe COPD and documented hyperinflation will undergo lung function measurements before and immediately after a 20-minute Simeox® session. The main measurement is the change in residual volume (RV), which is the amount of air left in the lungs after a full exhalation. We will also measure changes in other lung volumes, breathlessness, and any side effects. This is a single-arm pilot study enrolling 23 patients at one center in Italy (ASST Lodi). The study is non-profit and has been approved by the Ethics Committee Comitato Etico Territoriale Lombardia 1 (CET Lombardia 1).
Detailed description
Detailed Description Pulmonary hyperinflation is a key pathophysiological feature of advanced chronic obstructive pulmonary disease (COPD), resulting from air trapping due to airflow obstruction and reduced elastic recoil. It is strongly associated with dyspnea, exercise intolerance, and impaired quality of life. Reducing residual volume (RV) is therefore a clinically meaningful therapeutic target in patients with severe and very severe COPD.
Simeox® is a CE-marked electro-medical device currently used in clinical practice for bronchial secretion drainage. It applies intermittent negative pressure at high frequency (6-12 Hertz, Hz) during the expiratory phase, with the aim of increasing expiratory flow velocity and promoting air mobilization. While the device is routinely used in patients with bronchial hypersecretion, its potential effect on static lung volumes in patients with hyperinflation - regardless of the presence of significant secretions - has not been systematically investigated.
This prospective, single-arm, non-controlled pilot study aims to explore the immediate effect of a single Simeox® session on RV in patients with severe or very severe COPD and documented pulmonary hyperinflation.
Study procedure:
Each participant undergoes baseline lung function assessment using spirometry and nitrogen wash-out (N₂ wash-out), followed by a single Simeox® treatment session lasting approximately 20 minutes (4 series of 10 tidal breathing cycles in a seated position, with rest breaks according to tolerance). During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure modulated to the maximum tolerated intensity. Lung function measurements are repeated immediately after the session (within 30 minutes).
Safety monitoring:
Respiratory rate, heart rate, and peripheral oxygen saturation (SpO₂) are monitored throughout the session. Adverse events are recorded and classified by type, severity, and relationship to the treatment. Tolerability is assessed through subjective patient rating and dyspnea score variation.
Statistical analysis:
Pre- and post-intervention comparisons will be performed using a paired t-test or Wilcoxon signed-rank test depending on data distribution (significance level p < 0.05). Sample size was calculated based on a clinically meaningful RV reduction of 0.40 L (standard deviation, SD: 0.60 L), yielding a minimum of 21 patients (80% power, α = 0.05), with 23 patients planned to account for dropouts.
This pilot study will provide the methodological basis for designing a future randomized controlled trial (RCT) with a larger sample and longer follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simeox Treatment | Experimental | Device: SimeoxAll enrolled patients undergo a single session of treatment with the Simeox® device. Lung function is assessed before and immediately after the session. No control or comparator group is included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Diagnosis of severe or very severe COPD (GOLD stage 3-4)
- Documented pulmonary hyperinflation defined by at least one of the following criteria measured by nitrogen wash-out (N₂ wash-out):
- Residual volume (RV) > 150% of predicted
- Functional residual capacity (FRC) > 130% of predicted
Key exclusion criteria (18 listed)
- Active or recent pneumothorax (< 6 weeks), predisposition to pneumothorax or pneumomediastinum, or known pleural fragility
- Active or recent gross haemoptysis (< 6 weeks) or active pulmonary haemorrhage
- Haemodynamic instability
- Unstable cardiovascular conditions, including:
- Recent myocardial infarction
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 |
|---|---|---|
| SimeoxAlso: Intermittent Negative Pressure DeviceSingle treatment session of approximately 20 minutes with the Simeox® electro-medical device. The session consists of 4 series of 10 tidal breathing cycles performed in a seated position, with rest breaks according to patient tolerance. During each breathing cycle, the patient performs slow controlled exhalations while the device applies high-frequency intermittent negative pressure (6-12 Hz), modulated to the maximum tolerated intensity. Treatment efficacy is monitored through visual indicators integrated into the device. | Device | Simeox Treatment |
Primary outcome
Change in Residual Volume (RV)
Time frame: Baseline and within 30 minutes after the end of the treatment session
Absolute change in residual volume (ΔRV, liters) measured by nitrogen wash-out (N₂ wash-out) before and immediately after a single Simeox® treatment session
5 secondary outcomes
Change in Functional Residual Capacity (FRC)
Time frame: Baseline and within 30 minutes after the end of the treatment session
Change in Vital Capacity (VC)
Time frame: Baseline and within 30 minutes after the end of the treatment session
Change in Dyspnea Score
Time frame: Baseline and within 30 minutes after the end of the treatment session
Incidence of Adverse Events
Time frame: From the start of the treatment session up to 30 minutes after session completion
Treatment Tolerability
Time frame: From the start of the treatment session up to 30 minutes after session completion
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 24 Jun 2026.
- Background. Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed. Boca Raton: Chapman & Hall/CRC; 2008.
- Background: PubMed 22441742Hartman JE, Ten Hacken NH, Klooster K, Boezen HM, de Greef MH, Slebos DJ. The minimal important difference for residual volume in patients with severe emphysema. Eur Respir J. 2012 Nov;40(5):1137-41. doi: 10.1183/09031936.00219111. Epub 2012 Mar 22.
- Background: PubMed 11779727Fessler HE, Scharf SM, Permutt S. Improvement in spirometry following lung volume reduction surgery: application of a physiologic model. Am J Respir Crit Care Med. 2002 Jan 1;165(1):34-40. doi: 10.1164/ajrccm.165.1.2101149.
- Background: PubMed 15579725Hopkinson NS, Toma TP, Hansell DM, Goldstraw P, Moxham J, Geddes DM, Polkey MI. Effect of bronchoscopic lung volume reduction on dynamic hyperinflation and exercise in emphysema. Am J Respir Crit Care Med. 2005 Mar 1;171(5):453-60. doi: 10.1164/rccm.200407-961OC. Epub 2004 Dec 3.
- Background: PubMed 16135736Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
- Background: PubMed 17729066O'Donnell DE, Laveneziana P. Dyspnea and activity limitation in COPD: mechanical factors. COPD. 2007 Sep;4(3):225-36. doi: 10.1080/15412550701480455.
- Background: PubMed 19542481Garcia-Rio F, Lores V, Mediano O, Rojo B, Hernanz A, Lopez-Collazo E, Alvarez-Sala R. Daily physical activity in patients with chronic obstructive pulmonary disease is mainly associated with dynamic hyperinflation. Am J Respir Crit Care Med. 2009 Sep 15;180(6):506-12. doi: 10.1164/rccm.200812-1873OC. Epub 2009 Jun 19.
- Background: PubMed 18044095Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. doi: 10.2147/copd.2006.1.4.381.
- Background: PubMed 16996896Cooper CB. The connection between chronic obstructive pulmonary disease symptoms and hyperinflation and its impact on exercise and function. Am J Med. 2006 Oct;119(10 Suppl 1):21-31. doi: 10.1016/j.amjmed.2006.08.004.
- BackgroundGlobal Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, given the exploratory and pilot nature of the study, the small sample size (23 patients), and the need to protect participant privacy in accordance with Italian and European data protection regulations (GDPR). Aggregate results will be made publicly available through publication in a peer-reviewed journal and/or presentation at scientific conferences within 12 months of study completion, as required by the approving Ethics Committee (CET Lombardia 1).
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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.
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 Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hyperinflation, run by Azienda Socio Sanitaria Territoriale di Lodi 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 10 inclusion and 18 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 24 Jun 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 Andrea Di Matteo, dr (+393387123135, andrea.dimatteo@asst-lodi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Residual Volume (RV) (time frame: Baseline and within 30 minutes after the end of the treatment session). 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 NCT07665931, which also lists 10 linked publications.
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 24 Jun 2026.