COPD ExacerbationPhase 4O2flow-COPDNCT04223050
Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation
A Phase 4 study testing Oxygen gas in people with COPD Exacerbation and Chronic Obstructive Pulmonary Disease Exacerbation, run by Esbjerg Hospital - University Hospital of Southern Denmark at 4 sites in Denmark.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common disorder that affects approximately 400,000 Danish citizens. About 3,000-3,500 Danes die yearly because of the disorder, and the costs associated with hospital admissions are estimated to be 535 million Danish kroner (DKK). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation
- What is being tested?
- Oxygen gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesDenmark
- Study dates
- 3 Feb 2020to 31 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- ability to give informed consent
- previously diagnosed COPD (either confirmed diagnosis at prior hospital - contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication))
- admitted with acute exacerbation (acute and worsened shortness of breath) of COPD
- requiring oxygen treatment
Who cannot join
- Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes
- Expected total length of stay in hospital < 12 hours
- Planned transfer to another hospital within 12 hours
- Unwilling to have repeated arterial blood gas analyses within the first 12 hours
- Patients judged terminal by treating physician in the emergency department
- Non-residents of the particular country
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- Expected impossible follow-up
- Fertile women (<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
- Prior participation in the study
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Sydvestjysk Sygehus
Esbjerg, 6700
Holbæk Sygehus
Holbæk, 4300
Sygehus Lillebælt, Kolding
Kolding, 6000
Odense University Hospital
Odense, 5000
About this study
Official title: Will Titrated Oxygen Flow to a Peripheral Oxygen Saturation of 88-92% Compared With Oxygen Flow to a Saturation >94% Reduce Mortality in Chronic Obstructive Pulmonary Disease Patients With Acute Exacerbation? - a Randomized Clinical Trial
Chronic obstructive pulmonary disease (COPD) is a common disorder that affects approximately 400,000 Danish citizens. About 3,000-3,500 Danes die yearly because of the disorder, and the costs associated with hospital admissions are estimated to be 535 million Danish kroner (DKK). Patients with COPD risk a worsening of their disorder, and in most cases, this will require hospitalization. One of the used treatments is providing oxygen to the patients via e.g. masks. The recommendations on oxygen treatment are currently based on a study from 2010 where 37% of the participants in this study did not receive the intended treatment, which may have had massive effects on the results. It is worrying that no other studies have shown which oxygen treatment is safest for the patients. As such, we deem it important to study how best to treat the patients.
Our study is of high clinical relevance as hospitals receive patients with worsening of COPD daily. We need more, better data regarding the oxygen treatment of our patients, in order to provide our patients with the best possible care. The purpose of our study is thus to determine which oxygen treatment is best for patients with acute worsening of COPD symptoms. We will use a prospective, randomized controlled open-label trial. We will use two treatments: Treatment 1 is giving oxygen to the patient to reach a peripheral oxygen saturation of above 94%. Treatment 2 is giving oxygen to reach a peripheral oxygen saturation of between 88% and 92%.
Read more
Our primary outcome is 30-day all-cause mortality, with secondary outcomes being 7-day all-cause mortality, need for non-invasive ventilation, intubation or intensive care admission, over-all length of hospital stay and respiratory acidosis.
We believe that a lower oxygen saturation percentage may be superior as one study (Austin et al., 2010) showed a lower mortality rate in the group of patients that had a lower peripheral oxygen saturation. Additionally, the risk of respiratory acidosis and hypercapnia were lower. We wish to perform our study in the hospital sector as this study was performed in the prehospital sector and thus their results cannot be translated directly.
Read the detailed description
Please refer to the full protocol.
- Being tested
- Oxygen gas
- Keywords
- COPD, Oxygen treatment, Mortality
- 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.
Oxygen gasDrug
Administering oxygen to achieve the desired peripheral oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| High oxygen saturation | Active comparator | Peripheral oxygen saturation level >94% Receives: Drug: Oxygen gas |
| Low oxygen saturation | Active comparator | Peripheral oxygen saturation level 88-92% Receives: Drug: Oxygen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
Data is extracted from the Danish national registries.
Measured: 30 days
Secondary outcomes (6)
7-day all-cause mortality
Data is extracted from the Danish national registries.
Measured: 7 days
Non-invasive ventilation
The Medical records will be reviewed for documentation on if the patient has been on non-invasive ventilation. This will be reported as proportion of patients on NIV
Measured: 12 hours
Intubation
The Medical records will be reviewed for documentation on if the patient has been intubated. This will be reported as proportion of patients intubated
Measured: 12 hours
Intensive care admission
Extracted from the hospital records.
Measured: 1 day
Overall length of hospital stay
Time calculated from the hospital records
Measured: 10 days
Respiratory acidosis
Measured as an arterial blood gas analysis with pH > 7.35 and hypercapnia
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start3 Feb 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Why it stopped: Not possible to include patients at the required speed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomization will be performed as block randomization with a 1:1 allocation using an electronic randomization system accessible via the internet (REDCap via OPEN at the University of Southern Denmark). The participants will be randomized electronically bedside by the study representatives.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Holbaek Sygehus, Odense University Hospital, Sygehus Lillebaelt
- Responsible party
- Sponsor
- Investigators
- Peter Hallas, MD, Principal investigator, Holbaek SygehusSune Laugesen, MD, Principal investigator, Odense University HospitalSimon Thorgaard-Rasmussen, MD, Principal investigator, Sygehus Lillebælt, Kolding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223050
- Sponsor's protocol ID
- 2019-002498-80
- Other IDs
- 19/4298, 2019-002498-80, 2019
- Acronym
- O2flow-COPD
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: (Indsæt senere)
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Titrated Oxygen Flow to a Peripheral Oxygen Saturation of 88-92% Compared With Oxygen Flow to a Saturation >94% Reduce Mortality in Chronic Obstructive Pulmonary Disease Patients With Acute Exacerbation? - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04223050
- Acronym / sponsor ID
- O2flow-COPD / 2019-002498-80
- Keywords
- COPD, Oxygen treatment, Mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not possible to include patients at the required speed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Holbaek Sygehus, Odense University Hospital, Sygehus Lillebaelt
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 10 Jan 2020 (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.
Chronic obstructive pulmonary disease (COPD) is a common disorder that affects approximately 400,000 Danish citizens. About 3,000-3,500 Danes die yearly because of the disorder, and the costs associated with hospital admissions are estimated to be 535 million Danish kroner (DKK). Patients with COPD risk a worsening of their disorder, and in most cases, this will require hospitalization. One of the used treatments is providing oxygen to the patients via e.g. masks. The recommendations on oxygen treatment are currently based on a study from 2010 where 37% of the participants in this study did not receive the intended treatment, which may have had massive effects on the results. It is worrying that no other studies have shown which oxygen treatment is safest for the patients. As such, we deem it important to study how best to treat the patients.
Our study is of high clinical relevance as hospitals receive patients with worsening of COPD daily. We need more, better data regarding the oxygen treatment of our patients, in order to provide our patients with the best possible care. The purpose of our study is thus to determine which oxygen treatment is best for patients with acute worsening of COPD symptoms. We will use a prospective, randomized controlled open-label trial. We will use two treatments: Treatment 1 is giving oxygen to the patient to reach a peripheral oxygen saturation of above 94%. Treatment 2 is giving oxygen to reach a peripheral oxygen saturation of between 88% and 92%.
Our primary outcome is 30-day all-cause mortality, with secondary outcomes being 7-day all-cause mortality, need for non-invasive ventilation, intubation or intensive care admission, over-all length of hospital stay and respiratory acidosis.
We believe that a lower oxygen saturation percentage may be superior as one study (Austin et al., 2010) showed a lower mortality rate in the group of patients that had a lower peripheral oxygen saturation. Additionally, the risk of respiratory acidosis and hypercapnia were lower. We wish to perform our study in the hospital sector as this study was performed in the prehospital sector and thus their results cannot be translated directly.
Detailed description
Please refer to the full protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be performed as block randomization with a 1:1 allocation using an electronic randomization system accessible via the internet (REDCap via OPEN at the University of Southern Denmark). The participants will be randomized electronically bedside by the study representatives.
| Arm | Type | Receives |
|---|---|---|
| High oxygen saturation | Active comparator | Drug: Oxygen gasPeripheral oxygen saturation level >94% |
| Low oxygen saturation | Active comparator | Drug: Oxygen gasPeripheral oxygen saturation level 88-92% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 years or older
- ability to give informed consent
- previously diagnosed COPD (either confirmed diagnosis at prior hospital - contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication))
- admitted with acute exacerbation (acute and worsened shortness of breath) of COPD
- requiring oxygen treatment
Key exclusion criteria (9 listed)
- Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes
- Expected total length of stay in hospital < 12 hours
- Planned transfer to another hospital within 12 hours
- Unwilling to have repeated arterial blood gas analyses within the first 12 hours
- Patients judged terminal by treating physician in the emergency department
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 |
|---|---|---|
| Oxygen gasAdministering oxygen to achieve the desired peripheral oxygen saturation | Drug | High oxygen saturation, Low oxygen saturation |
Primary outcome
30-day all-cause mortality
Time frame: 30 days
Data is extracted from the Danish national registries.
6 secondary outcomes
7-day all-cause mortality
Time frame: 7 days
Non-invasive ventilation
Time frame: 12 hours
Intubation
Time frame: 12 hours
Intensive care admission
Time frame: 1 day
Overall length of hospital stay
Time frame: 10 days
Respiratory acidosis
Time frame: 12 hours
Results and safety
The study was stopped early (reason given: Not possible to include patients at the required speed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No. (Indsæt senere)
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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. This study is not recruiting at the moment.
Peter Hallas, MD principal investigator
Holbaek Sygehus
Sune Laugesen, MD principal investigator
Odense University Hospital
Simon Thorgaard-Rasmussen, MD principal investigator
Sygehus Lillebælt, Kolding
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen gas in people with COPD Exacerbation and Chronic Obstructive Pulmonary Disease Exacerbation, run by Esbjerg Hospital - University Hospital of Southern Denmark at 4 sites 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: Not possible to include patients at the required speed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.