Titrated versus standard oxygen for prehospital treatment of COPD exacerbations
Official title: Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
Run by Central Denmark Region · NCT05703919 · Data updated 2026-11-12
This trial tests whether giving oxygen adjusted to keep blood oxygen (SpO₂) at 88–92% instead of using 100% oxygen during prehospital treatment of adults 40 and older with suspected COPD exacerbations lowers 30-day death.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 1888 (estimated) |
| Sponsor | Central Denmark Region Academic / other |
| Locations | 1 site (Aarhus N) |
| Status | Recruiting |
| Started | June 2, 2025 |
| Main results expected | February 29, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT05703919 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40 or older in the Central Denmark Region with EMS-suspected acute COPD exacerbation who require inhaled bronchodilators in the prehospital setting.
✕Probably not a fit
Patients with bronchospasm due to asthma or non-COPD causes, known or suspected pregnancy, those already receiving assisted ventilation, inter-hospital transfers, or those with suspected acute coronary syndrome are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The STOP-COPD trial randomizes adults aged 40 and older with suspected acute COPD exacerbation treated by Emergency Medical Services in the Central Denmark Region to receive inhaled bronchodilators driven by either compressed air with supplemental oxygen titrated to SpO₂ 88–92% or by 100% compressed oxygen. The trial is patient-blinded, conducted in the prehospital setting, and enrolls 1,888 participants in a 1:1 parallel-group, superiority design. The primary outcome is 30-day all-cause mortality, and secondary outcomes include 24-hour and 7-day mortality, need for invasive or non-invasive ventilation, respiratory acidosis on hospital arrival, ICU admission and lengths of stay, patient-reported dyspnea, and readmission rates. Enrollment occurs under emergency research regulations with informed consent obtained as soon as feasible after hospital admission.
Why it matters
Potential benefit: If successful, titrated oxygen during prehospital bronchodilator treatment could reduce 30-day mortality and lower the risk of hypercapnia-related complications in COPD exacerbations.
How similar studies have gone: Previous in-hospital and some ambulance-based studies have suggested conservative, titrated oxygen targets can reduce hypercapnia and harm in COPD exacerbations, but high-quality randomized evidence specifically for nebulizer-driven oxygen in the prehospital setting is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over the age of 40 * EMT or Paramedic suspected AECOPD * Confirmed suspicion of COPD Exclusion Criteria: * Bronchospasm due to asthma, allergic reaction or non-COPD conditions * Known or suspected pregnancy * Prehospital Non-invasive, invasive or assisted bag mask ventilation * Allergy to inhaled bronchodilators (Salbutamol) * Inter-hospital transfer * More than 2 doses (5 mg salbutamol) inhalation drug, acute treatment by EMS (emergency medical service) personnel, before allocated treatment is initiated * Suspicion of acute coronary syndrome
Where it's running
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Prehospital Emergency Medical Servises, Central Denmark Region
Aarhus N, Denmark Recruiting
Study contacts
- Principal investigator: Martin F Gude, PhD — Central Denmark Region
- Study coordinator: Martin F Gude, PhD
- Email: martgude@rm.dk
- Phone: 0045 25343621
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.