How Simeox® affects air left in the lungs in severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, prospective pilot study enrolling adults with severe or very severe COPD and documented hyperinflation at a single center in Italy. Participants receive baseline lung function testing, then undergo a ~20-minute Simeox® session. The main outcome is the immediate change in residual volume, with additional measurements of other lung volumes, breathlessness, and any side effects. The study aims to explore whether this device can acutely reduce hyperinflation by promoting air mobilization during exhalation. It is non-randomized and does not include a control group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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)

Where it's running

• ASST Lodi - Presidio Ospedaliero di Codogno
  Codogno, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Andrea Di Matteo, dr
• Email: andrea.dimatteo@asst-lodi.it
• Phone: +393387123135

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• IOS-based platform to screen, diagnose, and manage COPD and asthma

  This study tests an Impulse Oscillometry system to screen for and diagnose COPD and asthma and to help predict flare-ups over about a year, involving adults in China.

  Recruiting Beijing Chao Yang Hospital · Beijing, Beijing Municipality · NCT07910409

• Targeted NMES to improve breathing and leg/extra muscle strength in COPD

  This study tests whether targeted neuromuscular electrical stimulation helps people with COPD see improvements in breathing muscle function and overall muscle strength.

  Recruiting Universitas Padjadjaran · Bandung, West Java · NCT07910006

• AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer

  This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.

  Recruiting Phase 2 AeroRx Therapeutics Inc. · London and 1 other locations · NCT07896252

• PBMT with a pulmonary rehab program for COPD patients

  A small randomized trial tests whether adding photobiomodulation therapy before exercise in a COPD pulmonary rehab program helps improve functional capacity.

  Recruiting Federal University of Health Science of Porto Alegre · Porto Alegre, Rio Grande do Sul · NCT07878884

• Controlled versus standard oxygen therapy for ICU COPD with acute exacerbation

  This trial tests whether keeping oxygen levels at 88-92% helps ICU patients with an acute COPD flare more than keeping levels above 94%.

  Recruiting Hôpital Universitaire Taher Sfar · Mahdia, Mahdia Governorate and 1 other locations · NCT07842510

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.