NCT05703919

Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,888 (estimated)
• Sponsor: Central Denmark Region · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• COPD Exacerbation
• COPD Exacerbation Acute

Interventions

Type	Name	Description
DRUG	Titrated Oxygen	Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
DRUG	Standard Oxygen	Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators

Timeline

• Start date: 2025-06-02
• Primary completion: 2027-05-31
• Completion: 2028-05-31
• First posted: 2023-01-30
• Last updated: 2025-06-10

Locations

1 site across 1 country: Denmark