A Phase 4 interventional study of Titrated Oxygen and Standard Oxygen in COPD Exacerbation and COPD Exacerbation Acute, sponsored by Central Denmark Region. Recruiting at 1 site in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Central Denmark Region · Phase 4, Interventional, and Treatment
Among 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark — 34 open to participants now, 42 under way, 8 of them phase 3. Pulmonary Disease, Chronic Obstructive · Denmark.
Among the 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark, this one is the 23rd largest by planned enrollment of the 209 interventional ones, is one of 13 that started in 2025, is one of 35 in phase 4, reaches primary completion later than 30 of the 41 other live ones, and was the 196th registered.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 1,888 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →34 of the 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →242 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 13 started in 2025.
Median enrollment 182 across the 209 interventional studies, 194 across the 33 observational. Of the 171 that completed or were terminated, 74 (43%) have results posted.
111 of 242 have an industry lead sponsor. The 10 most frequent:
Central Denmark Region is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Central Denmark Region has 2 studies filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
16 of the studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05878769Phase 3Hoffmann-La RocheA Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) | 2027-06-30 |
| NCT07555483Phase 3Grifols Therapeutics LLCA Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD) | 2027-09-30 |
| NCT06163131Aarhus University HospitalThe Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility | 2026-11-27 |
| NCT06677593Copenhagen University Hospital, HvidovreDetection of Electrodermal Activity in Pain 2 | 2026-12-01 |
| NCT07428785Copenhagen University Hospital, RigshospitaletPulmonary and Total Blood Volume in COPD | 2026-12-20 |
Among the 242 studies in Pulmonary Disease, Chronic Obstructive with a site in Denmark, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Titrated Oxygen
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.
Drug: Standard Oxygen
Titrated oxygen strategy - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 88-92%
Also known as: Oxygen titration to SpO₂ 88-92% and compressed atmospheric air as nebulizer driver
Standard care using compressed oxygen (100%) as driver for inhaled bronchodilators
Also known as: No SpO₂ target restriction and 100% compressed oxygen as nebulizer driver
Mortality, 30-day
Vital status assessed 30 days after randomization using hospital electronic medical records
Time frame: Day 30 from randomization
Mortality, 24-hour
Vital status assessed 24 hours after randomization using hospital electronic medical records
Time frame: 24 hours from randomization
Mortality, 7-day
Vital status assessed 7 days after randomization using hospital electronic medical records
Time frame: Day 7 from randomization
Length of hospital stay
Number of days from hospital admission to hospital discharge, collected from hospital electronic medical records
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 30 after discharge
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 9 months after primary results publication; data will remain available until de-identified data are no longer stored according to ICMJE recommendations and EU regulations.
Access criteria: Researchers must submit a methodologically sound proposal for use of the data. Access will be granted following review and approval by the local trial administration. A data-sharing agreement will be required.
Data sharing details ↗ · www.stop-copd.com
Started Jun 2025 (actual). Primary completion is estimated for Feb 2028, 32 months after the start.
Of 86 non-industry phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 32 months is above that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
Primary completion moved once since we started tracking on Sep 25, 2026: May 2027 → Feb 2028, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Pulmonary Disease, Chronic Obstructive →
Central Denmark Region