Chronic Obstructive Pulmonary Disease ExacerbationCOPEXNORNCT06105814
Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Rapid diagnostics in people with Chronic Obstructive Pulmonary Disease Exacerbation and Pneumonia, run by Vestre Viken Hospital Trust.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Exacerbation, Pneumonia, Respiratory Tract Infections
- What is being tested?
- Rapid diagnostics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2030
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admitted to the emergency room with a tentative diagnosis of AECOPD, and at least two of the following criteria, more than the daily variation,
- Increased dyspnea
- Increased cough
- Increased sputum production
- Need for change in medication due to AECOPD
- Signed informed consent. Among patients with temporal or permanent reduced ability to consent, close relatives and/or family members must be asked and may approve or reject participation on behalf of the patient. In cases where close relatives/family members are not available, study personnel may include patients according to conscious judgment.
- Patients will be informed about the study and included by dedicated and approved study personnel (study nurses or study doctors), not by the treating health personnel.
Who cannot join
- Pulmonary embolism, segmental or larger
- Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg/kg/min noradrenaline or equivalent dose of other vasopressor(s)
- Glasgow Coma Scale score 3
- Patients not eligible for lower airways sampling within the first 24 hours of admission
- Palliative situation with life expectancy < 1 week
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPEXNOR)
Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Acute exacerbations of COPD (AECOPD) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in AECOPD is conflicting. Microbiological sampling is often insufficient in the setting of AECOPD, and there is a lack of biomarkers distinguishing AECOPD caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. Overuse of antibiotics is the main driver of antimicrobial resistance (AMR), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of AECOPD.
COPEXNOR seeks to examine which samples give the highest microbiological yield in AECOPD, comparing induced sputum to nasopharyngeal swabs. We will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. The study aims to define the microbiological etiology causing AECOPD in the Norwegian COPD-population, and examine the lung microbiome over time. COPEXNOR will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.
- Conditions
- Chronic Obstructive Pulmonary Disease Exacerbation, Pneumonia, Respiratory Tract Infections
- Being tested
- Rapid diagnostics
- Medical subject headings
- Pneumonia, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnosticsDevice
Sputum sampes will in addition to standard diagnostics be investigated using a rapid diagnostic plattform (FilmArray)
| Study group | Role | What they receive |
|---|---|---|
| Standard diagnostics | No intervention | Standard microbiological diagnostics, with nasopharyngeal swab and induced sputum or endotracheal aspirate for real-time polymerase chain reaction (PCR) and culture, blood cultures and urinary antigen tests |
| Rapid diagnostics | Experimental | In addition to standard diagnostics, induced sputum or endotracheal aspirate analyzed with multiplex PCR (FilmArray). Receives: Device: Rapid diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve microbiological sampling strategies in AECOPD.
Proportion of AECOPD with a microbiologically verified diagnosis from sputum versus nasopharyngeal swab.
Measured: Within months to a year after study completion.
Improve microbiological diagnostic workflow for faster initiation of adequate antibiotic therapy.
Time to targeted antimicrobial therapy in hours.
Measured: Within months to a year after study completion.
Reduce the use of unnecessary broad antimicrobial therapy.
Proportion of patients with AECOPD who receive targeted antimicrobial therapy.
Measured: Within months to a year after study completion.
Increase knowledge of the microbiological etiology in AECOPD.
Microbiological etiology in AECOPD.
Measured: Within months to a year after study completion.
Increased understanding of the lung microbiome over time.
Identify differences in lung microbiome over time, both in AECOPD and stabile state.
Measured: 2-5 years after study completion
Biomarkers at protein level
Identifying biomarkers in blood and sputum that can help differentiate between bacterial and non-bacterial AECOPD
Measured: 2-5 years after study completion
Protein markers of the iron metabolism
Identifying dynamics in iron metabolism in light of etiology.
Measured: 2-5 years after study completion
Biomarkers at the transcriptional level
Identifying different transcriptomic profiles in different causes of AECOPD
Measured: 2-5 years after study completion
Biomarkers for predicting outcome
Identifying biomarkers that can predict outcome in AECOPD.
Measured: 2-5 years after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- COPEXNOR is a prospective, randomized controlled trial with two arms: (1) Standard microbiological diagnostics, with nasopharyngeal swab and induced sputum or endotracheal aspirate for real-time polymerase chain reaction (PCR) and culture, blood cultures and urinary antigen tests, and (2) in addition to (i), induced sputum or endotracheal aspirate analyzed with multiplex PCR (FilmArray).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Heggelund, MD, PhD, Principal investigator, Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen.Karl Erik Müller, MD, PhD, Study director, Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105814
- Sponsor's protocol ID
- DS-INF-COPEXNOR
- Acronym
- COPEXNOR
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data is likely to be made avaliable upon reasonable request. It has to be anonymized due to national regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPEXNOR)
- ClinicalTrials.gov ID
- NCT06105814
- Acronym / sponsor ID
- COPEXNOR / DS-INF-COPEXNOR
- Conditions
- Chronic Obstructive Pulmonary Disease Exacerbation, Pneumonia, Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Oct 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.
Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Acute exacerbations of COPD (AECOPD) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in AECOPD is conflicting. Microbiological sampling is often insufficient in the setting of AECOPD, and there is a lack of biomarkers distinguishing AECOPD caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. Overuse of antibiotics is the main driver of antimicrobial resistance (AMR), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of AECOPD.
COPEXNOR seeks to examine which samples give the highest microbiological yield in AECOPD, comparing induced sputum to nasopharyngeal swabs. We will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. The study aims to define the microbiological etiology causing AECOPD in the Norwegian COPD-population, and examine the lung microbiome over time. COPEXNOR will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- COPEXNOR is a prospective, randomized controlled trial with two arms: (1) Standard microbiological diagnostics, with nasopharyngeal swab and induced sputum or endotracheal aspirate for real-time polymerase chain reaction (PCR) and culture, blood cultures and urinary antigen tests, and (2) in addition to (i), induced sputum or endotracheal aspirate analyzed with multiplex PCR (FilmArray).
| Arm | Type | Receives |
|---|---|---|
| Standard diagnostics | No intervention | –Standard microbiological diagnostics, with nasopharyngeal swab and induced sputum or endotracheal aspirate for real-time polymerase chain reaction (PCR) and culture, blood cultures and urinary antigen tests |
| Rapid diagnostics | Experimental | Device: Rapid diagnosticsIn addition to standard diagnostics, induced sputum or endotracheal aspirate analyzed with multiplex PCR (FilmArray). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Admitted to the emergency room with a tentative diagnosis of AECOPD, and at least two of the following criteria, more than the daily variation,
- Signed informed consent. Among patients with temporal or permanent reduced ability to consent, close relatives and/or family members must be asked and may approve or reject participation on behalf of the patient. In cases where close relatives/family members are not available, study personnel may include patients according to conscious judgment.
- Patients will be informed about the study and included by dedicated and approved study personnel (study nurses or study doctors), not by the treating health personnel.
Key exclusion criteria (5 listed)
- Pulmonary embolism, segmental or larger
- Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg/kg/min noradrenaline or equivalent dose of other vasopressor(s)
- Glasgow Coma Scale score 3
- Patients not eligible for lower airways sampling within the first 24 hours of admission
- Palliative situation with life expectancy < 1 week
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 |
|---|---|---|
| Rapid diagnosticsSputum sampes will in addition to standard diagnostics be investigated using a rapid diagnostic plattform (FilmArray) | Device | Rapid diagnostics |
Primary outcome
Improve microbiological sampling strategies in AECOPD.
Time frame: Within months to a year after study completion.
Proportion of AECOPD with a microbiologically verified diagnosis from sputum versus nasopharyngeal swab.
Improve microbiological diagnostic workflow for faster initiation of adequate antibiotic therapy.
Time frame: Within months to a year after study completion.
Time to targeted antimicrobial therapy in hours.
Reduce the use of unnecessary broad antimicrobial therapy.
Time frame: Within months to a year after study completion.
Proportion of patients with AECOPD who receive targeted antimicrobial therapy.
Increase knowledge of the microbiological etiology in AECOPD.
Time frame: Within months to a year after study completion.
Microbiological etiology in AECOPD.
Increased understanding of the lung microbiome over time.
Time frame: 2-5 years after study completion
Identify differences in lung microbiome over time, both in AECOPD and stabile state.
Biomarkers at protein level
Time frame: 2-5 years after study completion
Identifying biomarkers in blood and sputum that can help differentiate between bacterial and non-bacterial AECOPD
Protein markers of the iron metabolism
Time frame: 2-5 years after study completion
Identifying dynamics in iron metabolism in light of etiology.
Biomarkers at the transcriptional level
Time frame: 2-5 years after study completion
Identifying different transcriptomic profiles in different causes of AECOPD
Biomarkers for predicting outcome
Time frame: 2-5 years after study completion
Identifying biomarkers that can predict outcome in AECOPD.
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 30 Oct 2023.
- Individual participant dataSharing planned: No. Research data is likely to be made avaliable upon reasonable request. It has to be anonymized due to national regulations.
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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.
Lars Heggelund, MD, PhD principal investigator
Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen.
Karl Erik Müller, MD, PhD study director
Medical department, Drammen hospital, Vestre Viken. Department of clinical science, faculty of medicine, University of Bergen.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid diagnostics in people with Chronic Obstructive Pulmonary Disease Exacerbation and Pneumonia, run by Vestre Viken Hospital Trust.
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Lars Heggelund, MD, PhD (+47 48285882, lars.heggelund@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve microbiological sampling strategies in AECOPD. (time frame: Within months to a year after study completion.). The study lists 9 primary outcomes in all. 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 30 Oct 2023.