Chronic Obstructive Pulmonary DiseasePhase 4NCT05052125
Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD)
A Phase 4 study testing Oxygen in people with Chronic Obstructive Pulmonary Disease, run by Mikkel Brabrand at 2 sites in Denmark.
Trial summary
As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesDenmark
- Study dates
- 16 Dec 2021to 31 Dec 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
2 sites in 1 country.
Denmark2 sites
Hospital of Southern Denmark, Esbjerg
Esbjerg, 6700
Kolding Hospital, Sygehus Lillebælt
Kolding, 6000
About this study
Official title: Substudy: Oxygen Therapy in COPD Patients - Oxidative Stress and Mortality
As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.
Read the detailed description
Studies have shown that oxidative stress plays a critical role in the pathogenesis of COPD and its comorbidities. Oxidative stress refers to a state in which the activity of oxidants (e.g. reactive oxygen species (ROS)) outweighs that of antioxidants. ROS can be introduced exogenously by for example cigarette smoke and atmospheric pollution, but is also produced endogenously as a byproduct of ATP production in mitochondria or from immune cells during oxidative burst. When high fractions of inspired oxygen are administered, excess O2 can lead to formation of additional ROS, which depletes antioxidants and induces an inflammation with leukocyte-derived inflammatory mediators migrating to the site of injury. In turn, this causes cellular hypertrophy, increased surfactant secretion, and cellular influx of monocytes and mast cells. During the final, fibrotic phase of oxygen toxicity, irreversible, persistent destruction of the pulmonary lining have occurred with collagen disposition, thickening of pulmonary interstitial space, and fibrosis.
This substudy therefore aim to investigate the relation between oxygen therapy in COPD patients admitted with acute exacerbation, oxidative stress, and mortality.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Oxygen
- Keywords
- oxygen, oxidative stress, 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.
OxygenDrug
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% Intervention: Drug: Oxygen gas Receives: Drug: Oxygen |
| Low oxygen saturation | Active comparator | Peripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress levels (systemic and lung 8-isopropane levels).
Measured: Immediately after study completion
Secondary outcomes (4)
Inflammation levels (systemic and lung IL-8 levels)
Measured: Immediately after study completion
7-day all-cause mortality and 30-day all-cause mortality
extracted from the Danish national registries
Measured: 30 days
over-all length of hospital stay
calculated from the hospital records
Measured: Immediately after study completion
respiratory acidosis
measured as an arterial blood gas analysis with pH < 7.35 and hypercapnia
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start16 Dec 2021
- Primary completion31 Aug 2024
- Study completion31 Dec 2024
Why it stopped: Lack of inclusion of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Brabrand
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Sponsor-investigator, Mikkel Brabrand, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052125
- Sponsor's protocol ID
- 2019-002498-80 substudy
- Other IDs
- 2019
- Status last verified
- Sep 2024
- First submitted
- 7 Sep 2021
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substudy: Oxygen Therapy in COPD Patients - Oxidative Stress and Mortality
- ClinicalTrials.gov ID
- NCT05052125
- Acronym / sponsor ID
- 2019-002498-80 substudy
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- oxygen, oxidative stress, mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion of patients
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mikkel BrabrandUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Sep 2021 (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.
As protocol NCT04223050. This substudy furthermore investigates the role of oxidative stress in the administration of oxygen in COPD patients.
Detailed description
Studies have shown that oxidative stress plays a critical role in the pathogenesis of COPD and its comorbidities. Oxidative stress refers to a state in which the activity of oxidants (e.g. reactive oxygen species (ROS)) outweighs that of antioxidants. ROS can be introduced exogenously by for example cigarette smoke and atmospheric pollution, but is also produced endogenously as a byproduct of ATP production in mitochondria or from immune cells during oxidative burst. When high fractions of inspired oxygen are administered, excess O2 can lead to formation of additional ROS, which depletes antioxidants and induces an inflammation with leukocyte-derived inflammatory mediators migrating to the site of injury. In turn, this causes cellular hypertrophy, increased surfactant secretion, and cellular influx of monocytes and mast cells. During the final, fibrotic phase of oxygen toxicity, irreversible, persistent destruction of the pulmonary lining have occurred with collagen disposition, thickening of pulmonary interstitial space, and fibrosis.
This substudy therefore aim to investigate the relation between oxygen therapy in COPD patients admitted with acute exacerbation, oxidative stress, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High oxygen saturation | Active comparator | Drug: OxygenPeripheral oxygen saturation level >94% Intervention: Drug: Oxygen gas |
| Low oxygen saturation | Active comparator | Drug: OxygenPeripheral oxygen saturation level 88-92% Intervention: Drug: Oxygen gas |
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 |
|---|---|---|
| OxygenAdministering oxygen to achieve the desired peripheral oxygen saturation | Drug | High oxygen saturation, Low oxygen saturation |
Primary outcome
Oxidative stress levels (systemic and lung 8-isopropane levels).
Time frame: Immediately after study completion
4 secondary outcomes
Inflammation levels (systemic and lung IL-8 levels)
Time frame: Immediately after study completion
7-day all-cause mortality and 30-day all-cause mortality
Time frame: 30 days
over-all length of hospital stay
Time frame: Immediately after study completion
respiratory acidosis
Time frame: Immediately after the procedure
Results and safety
The study was stopped early (reason given: Lack of inclusion of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 in people with Chronic Obstructive Pulmonary Disease, run by Mikkel Brabrand at 2 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 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: Lack of inclusion of patients). 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?
Oxidative stress levels (systemic and lung 8-isopropane levels). (time frame: Immediately after study completion). 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 2025.