COPD ExacerbationPhase 4STOP-COPDNCT05703919
Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Titrated Oxygen and Standard Oxygen in people with COPD Exacerbation and COPD Exacerbation Acute, run by Central Denmark Region at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation, COPD Exacerbation Acute
- What is being tested?
- Titrated Oxygen and Standard Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,888 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jun 2025to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 40
- EMT or Paramedic suspected AECOPD
- Confirmed suspicion of COPD
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Prehospital Emergency Medical Servises, Central Denmark Region
Aarhus N, 8200
About this study
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.
Read the 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
- Being tested
- Titrated Oxygen, Standard Oxygen
- Keywords
- Titrated Oxygen, COPD Exacerbation, Prehospital, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titrated OxygenDrug
Also called Oxygen titration to SpO₂ 88-92% and compressed atmospheric air as nebulizer driver
Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
Standard OxygenDrug
Also called No SpO₂ target restriction and 100% compressed oxygen as nebulizer driver
Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators
| Study group | Role | What they receive |
|---|---|---|
| Titrated Oxygen | Experimental | If the treating EMT or paramedic finds indications for inhaled bronchodilators, this will be done with compressed air 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 (end-tidal carbon dioxide) meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time oxygen can be titrated through this to a target SpO2 of 88-92%. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP (standard operating procedures).
Following scenarios regarding SpO2 can occur during treatment:
SpO2 <88%: Supplemental oxygen via the EtCO2-meter up to 10 l/min, if higher oxygen levels are needed oxygen will be used as driver for the nebulizer. If the SpO2 remains under 88% additional oxygen can be added via the EtCO2-meter.
SpO2 88-92%: No intervention.
SpO2 >92%: No intervention.
If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP. Receives: Drug: Titrated Oxygen |
| Standard Oxygen | Active comparator | If the treating EMT or paramedic finds indication for inhaled bronchodilators, this will be done with oxygen 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time mask the patient for group allocation. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP.
Following scenarios regarding SpO2 can occur during treatment:
SpO2 <88%: Supplemental oxygen via the EtCO2 -meter up to 10 l/min.
SpO2 88-92%: No intervention.
SpO2 >92%: No intervention.
If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP. Receives: Drug: Standard Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality, 30-day
Vital status assessed 30 days after randomization using hospital electronic medical records
Measured: Day 30 from randomization
Secondary outcomes (18)
Mortality, 24-hour
Vital status assessed 24 hours after randomization using hospital electronic medical records
Measured: 24 hours from randomization
Mortality, 7-day
Vital status assessed 7 days after randomization using hospital electronic medical records
Measured: Day 7 from randomization
Length of hospital stay
Number of days from hospital admission to hospital discharge, collected from hospital electronic medical records
Measured: Day 30 from randomization
ICU admission rate
Proportion of patients admitted to an intensive care unit during the index hospitalization, collected from the electronic hospital medical record
Measured: Day 30 from randomization
Length of ICU stay
Number of days spent in the intensive care unit during the index hospitalization, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
In-hospital need for NIV (non-invasive ventilation) within 24 hours
Use of non-invasive ventilation recorded within 24 hours of hospital admission, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
In-hospital need for NIV within 7 days
Use of non-invasive ventilation recorded within 7 days of hospital admission, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
In-hospital need for NIV within 30 days
Use of non-invasive ventilation recorded within 30 days of randomization, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
Time to NIV
Time from hospital admission to initiation of non-invasive ventilation, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 24 hours
Initiation of invasive mechanical ventilation within 24 hours of hospital admission, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 7 days
Initiation of invasive mechanical ventilation within 7 days of hospital admission, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 30 days
Initiation of invasive mechanical ventilation within 30 days of randomization, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
Time to invasive ventilation
Time from hospital admission to initiation of invasive mechanical ventilation, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
Proportion of patients with respiratory acidosis on arrival to hospital
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
Measured: Day 30 from randomization
The degree of acidosis based on the pH (potential of hydrogen) value
Lowest pH value measured from arterial blood gas within 30 minutes of hospital arrival, collected from the patient's electronic hospital medical record
Measured: Day 30 from randomization
Patient experienced dyspnoea on a verbal rating scale 0-10
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
Measured: Day 30 from randomization
Readmission rate
Proportion of patients readmitted to hospital within 30 days after discharge from index hospitalization, collected from the patient's electronic hospital medical record
Measured: Day 30 after discharge
Time to readmission
Number of days from hospital discharge to first hospital readmission within 30 days, collected from the patient's electronic hospital medical record
Measured: Day 30 after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start2 Jun 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, randomized 1:1, parallel groups, patient blinded, prehospital, single center, acute, superiority trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,888 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Denmark Region
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin F Gude, PhD, Principal investigator, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703919
- Sponsor's protocol ID
- 5925
- Other IDs
- 2022-502003-30-00
- Acronym
- STOP-COPD
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available to researchers whose proposed use of the data has been approved by the local administration. Data will be shared starting 9 months after publication of the primary results and will be accessible until data are no longer stored, according to current ICMJE recommendations and EU data protection regulations. All trial-related documents (e.g., protocol, statistical analysis plan) will be made publicly available on the trial website. Patient-related data will not be accessible on the website.
Publications
Jensen ASR, Valentin JB, Mulvad MG, Hagenau V, Skaarup SH, Johnsen SP, Vaeggemose U, Gude MF. Standard vs. targeted oxygen therapy prehospitally for chronic obstructive pulmonary disease (STOP-COPD): study protocol for a randomised controlled trial. Trials. 2024 Jan 25;25(1):85. doi: 10.1186/s13063-024-07920-5.
PubMed 38273393
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05703919
- Acronym / sponsor ID
- STOP-COPD / 5925
- Conditions
- COPD Exacerbation, COPD Exacerbation Acute
- Keywords
- Titrated Oxygen, COPD Exacerbation, Prehospital, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,888 participants (estimated)
- Lead sponsor
- Central Denmark RegionUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional, prospective, randomized 1:1, parallel groups, patient blinded, prehospital, single center, acute, superiority trial
| Arm | Type | Receives |
|---|---|---|
| Titrated Oxygen | Experimental | Drug: Titrated OxygenIf the treating EMT or paramedic finds indications for inhaled bronchodilators, this will be done with compressed air 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 (end-tidal carbon dioxide) meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time oxygen can be titrated through this to a target SpO2 of 88-92%. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP (standard operating procedures). Following scenarios regarding SpO2 can occur during treatment: SpO2 <88%: Supplemental oxygen via the EtCO2-meter up to 10 l/min, if higher oxygen levels are needed oxygen will be used as driver for the nebulizer. If the SpO2 remains under 88% additional oxygen can be added via the EtCO2-meter. SpO2 88-92%: No intervention. SpO2 >92%: No intervention. If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP. |
| Standard Oxygen | Active comparator | Drug: Standard OxygenIf the treating EMT or paramedic finds indication for inhaled bronchodilators, this will be done with oxygen 6-8 l/min. as the driver for the nebulizer. The patient will have a Bi-nasal EtCO2 meter placed under the nebulizer. This will measure the EtCO2 during the treatment and at the same time mask the patient for group allocation. Repeated treatment will be at the discretion of the treating EMT or paramedic according to SOP. Following scenarios regarding SpO2 can occur during treatment: SpO2 <88%: Supplemental oxygen via the EtCO2 -meter up to 10 l/min. SpO2 88-92%: No intervention. SpO2 >92%: No intervention. If repeated treatment is not indicated the patient receives oxygen to SpO2 88-92% according SOP. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 40
- EMT or Paramedic suspected AECOPD
- Confirmed suspicion of COPD
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titrated OxygenAlso: Oxygen titration to SpO₂ 88-92% and compressed atmospheric air as nebulizer driverTitrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92% | Drug | Titrated Oxygen |
| Standard OxygenAlso: No SpO₂ target restriction and 100% compressed oxygen as nebulizer driverStandard care using compressed oxygen (100%) as driver for inhaled bronchodilators | Drug | Standard Oxygen |
Primary outcome
Mortality, 30-day
Time frame: Day 30 from randomization
Vital status assessed 30 days after randomization using hospital electronic medical records
18 secondary outcomes
Mortality, 24-hour
Time frame: 24 hours from randomization
Mortality, 7-day
Time frame: Day 7 from randomization
Length of hospital stay
Time frame: Day 30 from randomization
ICU admission rate
Time frame: Day 30 from randomization
Length of ICU stay
Time frame: Day 30 from randomization
In-hospital need for NIV (non-invasive ventilation) within 24 hours
Time frame: Day 30 from randomization
In-hospital need for NIV within 7 days
Time frame: Day 30 from randomization
In-hospital need for NIV within 30 days
Time frame: Day 30 from randomization
Time to NIV
Time frame: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 24 hours
Time frame: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 7 days
Time frame: Day 30 from randomization
In-hospital need for invasive mechanical ventilation within 30 days
Time frame: Day 30 from randomization
Time to invasive ventilation
Time frame: Day 30 from randomization
Proportion of patients with respiratory acidosis on arrival to hospital
Time frame: Day 30 from randomization
The degree of acidosis based on the pH (potential of hydrogen) value
Time frame: Day 30 from randomization
Patient experienced dyspnoea on a verbal rating scale 0-10
Time frame: Day 30 from randomization
Readmission rate
Time frame: Day 30 after discharge
Time to readmission
Time frame: Day 30 after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 38273393Jensen ASR, Valentin JB, Mulvad MG, Hagenau V, Skaarup SH, Johnsen SP, Vaeggemose U, Gude MF. Standard vs. targeted oxygen therapy prehospitally for chronic obstructive pulmonary disease (STOP-COPD): study protocol for a randomised controlled trial. Trials. 2024 Jan 25;25(1):85. doi: 10.1186/s13063-024-07920-5.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available to researchers whose proposed use of the data has been approved by the local administration. Data will be shared starting 9 months after publication of the primary results and will be accessible until data are no longer stored, according to current ICMJE recommendations and EU data protection regulations. All trial-related documents (e.g., protocol, statistical analysis plan) will be made publicly available on the trial website. Patient-related data will not be accessible on the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin F Gude, PhD principal investigator
Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Titrated Oxygen and Standard Oxygen in people with COPD Exacerbation and COPD Exacerbation Acute, run by Central Denmark Region at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin F Gude, PhD (0045 25343621, martgude@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality, 30-day (time frame: Day 30 from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05703919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.