NCT05703919 Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
| NCT ID | NCT05703919 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Central Denmark Region |
| Condition | COPD Exacerbation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,888 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,888 participants in total. It began in 2025-06-02 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The STOP-COPD trial is a randomized, patient-blinded, prehospital clinical trial designed to evaluate the effect of titrated oxygen therapy compared to standard oxygen treatment in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The primary objective is to determine whether a titrated oxygen strategy targeting SpO₂ 88-92% can reduce 30-day mortality compared to the current standard practice using 100% compressed oxygen as a nebulizer driver.
Eligibility 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
Contact & Investigator
Martin F Gude, PhD
PRINCIPAL INVESTIGATOR
Central Denmark Region
Frequently Asked Questions
Who can join the NCT05703919 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD Exacerbation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05703919 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05703919 currently recruiting?
Yes, NCT05703919 is actively recruiting participants. Contact the research team at martgude@rm.dk for enrollment information.
Where is the NCT05703919 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT05703919 clinical trial?
NCT05703919 is sponsored by Central Denmark Region. The principal investigator is Martin F Gude, PhD at Central Denmark Region. The trial plans to enroll 1,888 participants.
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