Central Denmark Region
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.
COPD Exacerbation
COPD Exacerbation Acute
Titrated Oxygen
Standard Oxygen
PHASE4
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality globally. In the prehospital setting, patients with suspected acute exacerbation of COPD (AECOPD) are frequently treated with inhaled bronchodilators driven by 100% oxygen, despite concerns that high-concentration oxygen therapy may worsen hypercapnia and acidosis, leading to increased mortality. The STOP-COPD trial is a prospective, randomized, parallel-group, superiority trial conducted in the Prehospital Emergency Medical Services, Central Denmark Region. Patients aged 40 years or older with suspected AECOPD requiring inhaled bronchodilators are randomized 1:1 to receive either: Titrated oxygen therapy: Inhaled bronchodilators driven by compressed air with supplemental oxygen titrated to maintain SpO₂ 88-92%. Standard treatment: Inhaled bronchodilators driven by 100% compressed oxygen according to standard protocols. The primary outcome is 30-day all-cause mortality. Secondary outcomes include 24-hour and 7-day mortality, need for invasive or non-invasive ventilation, development of respiratory acidosis upon hospital arrival, ICU admission rate, length of hospital and ICU stay, patient-experienced dyspnoea, and readmission rates. A total of 1,888 patients will be enrolled. The study is conducted under emergency research regulations allowing enrolment before informed consent, with consent obtained as soon as feasible after hospital admission. This trial seeks to evaluate whether titrating oxygen delivery in the prehospital phase can improve survival and clinical outcomes for patients with AECOPD.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 1888 participants |
| Masking : | SINGLE |
| Masking Description : | The trial will be single blinded. The patients will be blinded to treatment allocation. The EMTs (emergency medical technicians) or paramedics will not be blinded because of practical, ethical and security problems with carrying compressed gas without known content in an ambulance. As part of study informed and training, the EMT's and paramedics will be attentive to keep all AECOPD suspected patients blinded to the treatment allocated. |
| Primary Purpose : | TREATMENT |
| Official Title : | Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease |
| Actual Study Start Date : | 2025-06-02 |
| Estimated Primary Completion Date : | 2027-05-31 |
| Estimated Study Completion Date : | 2028-05-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Prehospital Emergency Medical Servises, Central Denmark Region
Aarhus N, Denmark, 8200