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NCT Number: NCT05703919

Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

COPD Exacerbation COPD Exacerbation Acute Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prehospital Emergency Medical Servises, Central Denmark Region

Aarhus N, 8200, Denmark

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Titrated Oxygen

Drug

Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%

Other names: Oxygen titration to SpO₂ 88-92% and compressed atmospheric air as nebulizer driver

Standard Oxygen

Drug

Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators

Other names: No SpO₂ target restriction and 100% compressed oxygen as nebulizer driver

Primary outcomes

  1. Mortality, 30-day

    Time frame: Day 30 from randomization

    Vital status assessed 30 days after randomization using hospital electronic medical records

Secondary outcomes

  1. Mortality, 24-hour

    Time frame: 24 hours from randomization

    Vital status assessed 24 hours after randomization using hospital electronic medical records

  2. Mortality, 7-day

    Time frame: Day 7 from randomization

    Vital status assessed 7 days after randomization using hospital electronic medical records

  3. Length of hospital stay

    Time frame: Day 30 from randomization

    Number of days from hospital admission to hospital discharge, collected from hospital electronic medical records

  4. ICU admission rate

    Time frame: Day 30 from randomization

    Proportion of patients admitted to an intensive care unit during the index hospitalization, collected from the electronic hospital medical record

  5. Length of ICU stay

    Time frame: Day 30 from randomization

    Number of days spent in the intensive care unit during the index hospitalization, collected from the patient's electronic hospital medical record

  6. In-hospital need for NIV (non-invasive ventilation) within 24 hours

    Time frame: Day 30 from randomization

    Use of non-invasive ventilation recorded within 24 hours of hospital admission, collected from the patient's electronic hospital medical record

  7. In-hospital need for NIV within 7 days

    Time frame: Day 30 from randomization

    Use of non-invasive ventilation recorded within 7 days of hospital admission, collected from the patient's electronic hospital medical record

  8. In-hospital need for NIV within 30 days

    Time frame: Day 30 from randomization

    Use of non-invasive ventilation recorded within 30 days of randomization, collected from the patient's electronic hospital medical record

  9. Time to NIV

    Time frame: Day 30 from randomization

    Time from hospital admission to initiation of non-invasive ventilation, collected from the patient's electronic hospital medical record

  10. In-hospital need for invasive mechanical ventilation within 24 hours

    Time frame: Day 30 from randomization

    Initiation of invasive mechanical ventilation within 24 hours of hospital admission, collected from the patient's electronic hospital medical record

  11. In-hospital need for invasive mechanical ventilation within 7 days

    Time frame: Day 30 from randomization

    Initiation of invasive mechanical ventilation within 7 days of hospital admission, collected from the patient's electronic hospital medical record

  12. In-hospital need for invasive mechanical ventilation within 30 days

    Time frame: Day 30 from randomization

    Initiation of invasive mechanical ventilation within 30 days of randomization, collected from the patient's electronic hospital medical record

  13. Time to invasive ventilation

    Time frame: Day 30 from randomization

    Time from hospital admission to initiation of invasive mechanical ventilation, collected from the patient's electronic hospital medical record

  14. Proportion of patients with respiratory acidosis on arrival to hospital

    Time frame: Day 30 from randomization

    Presence of respiratory acidosis (PaCO₂ >6.3 kPa and pH <7.35) assessed via arterial blood gas analysis within 30 minutes after arrival, collected from the patient's electronic hospital medical record

  15. The degree of acidosis based on the pH (potential of hydrogen) value

    Time frame: Day 30 from randomization

    Lowest pH value measured from arterial blood gas within 30 minutes of hospital arrival, collected from the patient's electronic hospital medical record

  16. Patient experienced dyspnoea on a verbal rating scale 0-10

    Time frame: Day 30 from randomization

    Patient-reported dyspnoea score at hospital arrival on a scale from 0 (no dyspnoea) to 10 (worst imaginable dyspnoea), collected from the prehospital patient record and hospital medical record

  17. Readmission rate

    Time frame: Day 30 after discharge

    Proportion of patients readmitted to hospital within 30 days after discharge from index hospitalization, collected from the patient's electronic hospital medical record

  18. Time to readmission

    Time frame: Day 30 after discharge

    Number of days from hospital discharge to first hospital readmission within 30 days, collected from the patient's electronic hospital medical record

Study contacts

Contact information is provided by the study sponsor or research team.

Arne Sylvester R Jensen

CONTACT

[email protected]

22396968

Martin F Gude, PhD

CONTACT

[email protected]

0045 25343621

Sponsors and collaborators

Lead sponsor

Central Denmark Region

Other

Registry information

Acronym: STOP-COPD

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 30, 2023
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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