Chronic Obstructive Pulmonary DiseaseA-TRECNCT06188065
Eosinopenia in Severe COPD Exacerbation
An observational study of Chronic Obstructive Pulmonary Disease, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goals of this observational study are to identify factors independently associated with admission eosinopenia in patients with a severe exacerbation of chronic obstructive pulmonary disease (COPD) and to determine when blood eosinophil count (BEC) will recover to baseline stable state in patients who are admitted… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Blood eosinophil count
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jan 2024to Jul 2026
- Phase
- Observational
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be aged 35 years and over. They will have been admitted to hospital with an exacerbation of COPD +/- eosinopenia.
Who may be able to join
- Admitted to hospital with primary clinical diagnosis of exacerbation of COPD*
- Smoking history of at least 10 pack years
- Airflow obstruction: FEV1/FVC ratio < 0.7 confirmed on historic or inpatient spirometry
- Capacity to give informed consent to participate
- Eosinopenia on admission
- Uneventful recovery*
- Eosinopenia on admission who do not receive a further course of systemic corticosteroids or require emergency hospital admission for an acute illness in the six weeks following admission to hospital with a severe exacerbation of COPD.
Who cannot join
- Parasitic infection, systemic fungal infection (excluding infection limited to nails or skin), eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome or other conditions associated with a high eosinophil count#
- Active malignancy
- Maintenance oral prednisolone or other systemic steroids, anti-interleukin 5 therapy or other medication known to influence eosinophils
- Patients with poor venous access
- Investigator confirmed history of asthma
- Non-COPD related health problems which in the view of the primary investigator may compromise the conduct and completion of the study
- ADDITIONAL CRITERIA FOR THE TIME TO RECOVERY FROM EOSINOPENIA ANALYSIS ONLY
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peter Ireland, MBBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
Northumbria Healthcare NHS Foundation Trust
North Shields
Peter Ireland, MBBS, peter.ireland@northumbria-healthcare.nhs.uk
About this study
Official title: Associates of, and Time to Recovery From, Eosinopenia in Severe COPD Exacerbation
The goals of this observational study are to identify factors independently associated with admission eosinopenia in patients with a severe exacerbation of chronic obstructive pulmonary disease (COPD) and to determine when blood eosinophil count (BEC) will recover to baseline stable state in patients who are admitted to hospital with a severe exacerbation of COPD and associated eosinopenia.
The main aims of the study are to:
- Identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD
- Assess the time to recovery from eosinopenia to stable BEC following a severe exacerbation of COPD
Read the detailed description
Blood eosinophils are a type of white blood cell that play a role in the immune system including fighting infection. They have numerous roles but are primarily involved in inflammation. They are recruited from the blood into sites of inflammation.
The blood eosinophil count (BEC) can be used as a biomarker to predict whether the addition of inhaled corticosteroid (ICS) to long-acting bronchodilators (LABD) will be beneficial in reducing future COPD exacerbations. This association is based on BEC being measured when patients are clinically stable. Patients with a higher BEC are more likely to gain these benefits where as conversely, patients with a lower BEC are less likely to benefit and the risk of side effects such as pneumonia will likely outweigh any potential benefit. Current national and international COPD guidelines suggest the use of BEC as a biomarker to help inform the decision of whether to commence or withdraw ICS, but do not specify measuring BEC at a time of clinical stability.
Decisions regarding changes to management are often made in the acute setting. Eosinophils transiently drop to very low levels in half of patients who are admitted to hospital with exacerbations of COPD. Measuring BEC during an acute illness risks incorrectly identifying all patients who may benefit from the introduction of an ICS. In the current BEC COPD study, reliance on admission and discharge BEC inappropriately denied ICS to 47% and 33% of patients respectively compared to a confirmed stable-state measure.
There are co-primary aims for this study. Firstly, the investigators wish to determine when BEC will recover to stable state following a hospital admission for exacerbation of COPD. Determining this will inform healthcare professionals of the optimum time to measure BEC for use as a biomarker when making decisions related to management escalation. Based on the results of BEC COPD, it is likely that an increased number of patients will be identified as being above the BEC threshold and therefore likely to benefit from ICS when time is allowed for BEC to recover to stable state. Appropriate introduction of ICS in this patient group will reduce exacerbation and hospital re-admission rates and thus may reduce overall mortality within this high-risk group. This should reduce the burden of COPD on patient's health, quality of life and the NHS.
Eosinopenia during severe exacerbation of COPD is associated with increased in-hospital and one year mortality. Treatment with oral corticosteroids does not fully explain the mechanism behind the development of eosinopenia, with the phenomenon being less common on discharge compared to admission despite inpatient oral corticosteroid treatment. The investigators other co-primary aim is to identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD, providing useful mechanistic information regarding the relationship between BEC and short-term mortality.
The hypothesis for this study is that 90% of participants who are admitted to hospital with a severe exacerbation of COPD and eosinopenia will have recovery of their BEC to baseline stable state within 4 weeks. The investigators also hypothesize that there are demographic, physiological and clinical factors independently associated with admission eosinopenia other than prior systemic corticosteroid use.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Blood eosinophil count
- 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.
Blood eosinophil countDiagnostic test
To determine the time it takes for blood eosinophil count to recover to baseline stable state following severe exacerbation of COPD associated with admission eosinopenia and to explore independent factors associated with admission eosinopenia.
| Study group | Role | What they receive |
|---|---|---|
| Participants with severe exacerbation of COPD and eosinophils < 0.05 x 10^9/L | Participants to be included in the co-primary outcomes for the time to recovery from eosinopenia analysis as well as the analysis to identify independent factors associated with eosinopenia on admission in patients with a severe exacerbation of COPD. This group of participants will also be included in all secondary outcomes. Receives: Diagnostic Test: Blood eosinophil count | |
| Participants with severe exacerbation of COPD and eosinophils >= 0.05 x 10^9/L | Participants will be included in the co-primary outcome to identify independent factors associated with eosinopenia on admission in patients with a severe exacerbation of COPD. This group of participants will also be included in some of the secondary outcomes. Receives: Diagnostic Test: Blood eosinophil count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indices independently associated with eosinopenia on admission in patients with a severe exacerbation of COPD.
Candidate indices will be identified by both univariate analysis (inclusion of indices related to eosinopenia at the 0.1 threshold) and domain knowledge (inclusion of indices thought likely to be related to eosinopenia even if no association on univariate analysis). Summary indices will also be created to reduce the number of variables (e.g. evidence of bacterial infection will include positive blood culture, sputum culture or antigens). Once candidate indices have been identifed, collinearity will be addressed and then independent associates of eosinopenia will be identified by logistic regression using backwards stepwise elimination.
Measured: On admission date
The time taken for BEC to recover to stable state following a severe exacerbation of COPD.
Measured: 1, 2, 3, 4 and 6 weeks from admission date
Secondary outcomes (6)
Level of agreement between the index admission eosinophil phenotype and prior admissions for exacerbations of COPD since May 2019.
Measured: On admission date
Change from baseline cytokine levels at day 28m stratified by intercurrent exacerbation or other acute illness status, including sub-group analysis (eosinopenic cohort vs non-eosinopenic cohort)
Measured: On admission date and 4 weeks from admission date
The proportion of patients whose BEC reaches 100 cell/uL or higher at each visit.
Measured: 1, 2, 3, 4 and 6 weeks from admission date
The time taken to reach peak BEC after a severe exacerbation of COPD.
Measured: 1, 2, 3, 4 and 6 weeks from admission date
Exploratory analysis looking for patient and treatment associations with rate of recovery of BEC.
Patient and treatment variables associated with rate of recovery of BEC will be identified using univariate analysis.
Measured: 1, 2, 3, 4 and 6 weeks from admission date
Comparison of the rate of recovery of BEC in patients who had further exacerbations of COPD within the study period and patients who have not had further exacerbations.
Measured: 1, 2, 3, 4 and 6 weeks from admission date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start22 Jan 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria Healthcare NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Chiesi UK, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Stephen Bourke, MBChB, PhD, Study chair, Northumbria Healthcare NHS Foundation TrustPeter Ireland, MBBS, Principal investigator, Northumbria Healthcare NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188065
- Sponsor's protocol ID
- SCI65
- Acronym
- A-TREC
- Status last verified
- Apr 2026
- First submitted
- 15 Dec 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
PubMed 29331313Singh D, Agusti A, Martinez FJ, Papi A, Pavord ID, Wedzicha JA, Vogelmeier CF, Halpin DMG. Blood Eosinophils and Chronic Obstructive Pulmonary Disease: A Global Initiative for Chronic Obstructive Lung Disease Science Committee 2022 Review. Am J Respir Crit Care Med. 2022 Jul 1;206(1):17-24. doi: 10.1164/rccm.202201-0209PP. No abstract available.
PubMed 35737975Suissa S, Ernst P. Precision Medicine Urgency: The Case of Inhaled Corticosteroids in COPD. Chest. 2017 Aug;152(2):227-231. doi: 10.1016/j.chest.2017.05.020. No abstract available.
PubMed 28797382Global Strategy for Prevention, Diagnosis and Management of COPD: 2023 Report. Global Initiative for Chronic Obstructive Lung Disease, 2023.
Steer J, Gibson J, Bourke SC. The DECAF Score: predicting hospital mortality in exacerbations of chronic obstructive pulmonary disease. Thorax. 2012 Nov;67(11):970-6. doi: 10.1136/thoraxjnl-2012-202103. Epub 2012 Aug 15.
PubMed 22895999Prasad A, Echevarria C, Steer J, Bourke S C. Blood eosinophil counts during severe exacerbations do not reflect stable state inflammatory phenotype in COPD. European Respiratory Journal 2022 60: 1870.
Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.
PubMed 29668352Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC.
PubMed 32162970Echevarria C, Steer J, Prasad A, Quint JK, Bourke SC. Admission blood eosinophil count, inpatient death and death at 1 year in exacerbating patients with COPD. Thorax. 2023 Nov;78(11):1090-1096. doi: 10.1136/thorax-2022-219463. Epub 2023 Jul 24.
PubMed 37487711
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associates of, and Time to Recovery From, Eosinopenia in Severe COPD Exacerbation
- ClinicalTrials.gov ID
- NCT06188065
- Acronym / sponsor ID
- A-TREC / SCI65
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northumbria Healthcare NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Newcastle University, Chiesi UK, GlaxoSmithKline
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Jan 2024 (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 goals of this observational study are to identify factors independently associated with admission eosinopenia in patients with a severe exacerbation of chronic obstructive pulmonary disease (COPD) and to determine when blood eosinophil count (BEC) will recover to baseline stable state in patients who are admitted to hospital with a severe exacerbation of COPD and associated eosinopenia.
The main aims of the study are to:
- Identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD
- Assess the time to recovery from eosinopenia to stable BEC following a severe exacerbation of COPD
Detailed description
Blood eosinophils are a type of white blood cell that play a role in the immune system including fighting infection. They have numerous roles but are primarily involved in inflammation. They are recruited from the blood into sites of inflammation.
The blood eosinophil count (BEC) can be used as a biomarker to predict whether the addition of inhaled corticosteroid (ICS) to long-acting bronchodilators (LABD) will be beneficial in reducing future COPD exacerbations. This association is based on BEC being measured when patients are clinically stable. Patients with a higher BEC are more likely to gain these benefits where as conversely, patients with a lower BEC are less likely to benefit and the risk of side effects such as pneumonia will likely outweigh any potential benefit. Current national and international COPD guidelines suggest the use of BEC as a biomarker to help inform the decision of whether to commence or withdraw ICS, but do not specify measuring BEC at a time of clinical stability.
Decisions regarding changes to management are often made in the acute setting. Eosinophils transiently drop to very low levels in half of patients who are admitted to hospital with exacerbations of COPD. Measuring BEC during an acute illness risks incorrectly identifying all patients who may benefit from the introduction of an ICS. In the current BEC COPD study, reliance on admission and discharge BEC inappropriately denied ICS to 47% and 33% of patients respectively compared to a confirmed stable-state measure.
There are co-primary aims for this study. Firstly, the investigators wish to determine when BEC will recover to stable state following a hospital admission for exacerbation of COPD. Determining this will inform healthcare professionals of the optimum time to measure BEC for use as a biomarker when making decisions related to management escalation. Based on the results of BEC COPD, it is likely that an increased number of patients will be identified as being above the BEC threshold and therefore likely to benefit from ICS when time is allowed for BEC to recover to stable state. Appropriate introduction of ICS in this patient group will reduce exacerbation and hospital re-admission rates and thus may reduce overall mortality within this high-risk group. This should reduce the burden of COPD on patient's health, quality of life and the NHS.
Eosinopenia during severe exacerbation of COPD is associated with increased in-hospital and one year mortality. Treatment with oral corticosteroids does not fully explain the mechanism behind the development of eosinopenia, with the phenomenon being less common on discharge compared to admission despite inpatient oral corticosteroid treatment. The investigators other co-primary aim is to identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD, providing useful mechanistic information regarding the relationship between BEC and short-term mortality.
The hypothesis for this study is that 90% of participants who are admitted to hospital with a severe exacerbation of COPD and eosinopenia will have recovery of their BEC to baseline stable state within 4 weeks. The investigators also hypothesize that there are demographic, physiological and clinical factors independently associated with admission eosinopenia other than prior systemic corticosteroid use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with severe exacerbation of COPD and eosinophils < 0.05 x 10^9/L | – | Diagnostic Test: Blood eosinophil countParticipants to be included in the co-primary outcomes for the time to recovery from eosinopenia analysis as well as the analysis to identify independent factors associated with eosinopenia on admission in patients with a severe exacerbation of COPD. This group of participants will also be included in all secondary outcomes. |
| Participants with severe exacerbation of COPD and eosinophils >= 0.05 x 10^9/L | – | Diagnostic Test: Blood eosinophil countParticipants will be included in the co-primary outcome to identify independent factors associated with eosinopenia on admission in patients with a severe exacerbation of COPD. This group of participants will also be included in some of the secondary outcomes. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be aged 35 years and over. They will have been admitted to hospital with an exacerbation of COPD +/- eosinopenia.
Key inclusion criteria (7 listed)
- Admitted to hospital with primary clinical diagnosis of exacerbation of COPD*
- Smoking history of at least 10 pack years
- Airflow obstruction: FEV1/FVC ratio < 0.7 confirmed on historic or inpatient spirometry
- Capacity to give informed consent to participate
- Eosinopenia on admission
Key exclusion criteria (7 listed)
- Parasitic infection, systemic fungal infection (excluding infection limited to nails or skin), eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome or other conditions associated with a high eosinophil count#
- Active malignancy
- Maintenance oral prednisolone or other systemic steroids, anti-interleukin 5 therapy or other medication known to influence eosinophils
- Patients with poor venous access
- Investigator confirmed history of asthma
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 |
|---|---|---|
| Blood eosinophil countTo determine the time it takes for blood eosinophil count to recover to baseline stable state following severe exacerbation of COPD associated with admission eosinopenia and to explore independent factors associated with admission eosinopenia. | Diagnostic test | Participants with severe exacerbation of COPD and eosinophils < 0.05 x 10^9/L, Participants with severe exacerbation of COPD and eosinophils >= 0.05 x 10^9/L |
Primary outcome
Indices independently associated with eosinopenia on admission in patients with a severe exacerbation of COPD.
Time frame: On admission date
Candidate indices will be identified by both univariate analysis (inclusion of indices related to eosinopenia at the 0.1 threshold) and domain knowledge (inclusion of indices thought likely to be related to eosinopenia even if no association on univariate analysis). Summary indices will also be created to reduce the number of variables (e.g. evidence of bacterial infection will include positive blood culture, sputum culture or antigens). Once candidate indices have been identifed, collinearity will be addressed and then independent associates of eosinopenia will be identified by logistic regression using backwards stepwise elimination.
The time taken for BEC to recover to stable state following a severe exacerbation of COPD.
Time frame: 1, 2, 3, 4 and 6 weeks from admission date
6 secondary outcomes
Level of agreement between the index admission eosinophil phenotype and prior admissions for exacerbations of COPD since May 2019.
Time frame: On admission date
Change from baseline cytokine levels at day 28m stratified by intercurrent exacerbation or other acute illness status, including sub-group analysis (eosinopenic cohort vs non-eosinopenic cohort)
Time frame: On admission date and 4 weeks from admission date
The proportion of patients whose BEC reaches 100 cell/uL or higher at each visit.
Time frame: 1, 2, 3, 4 and 6 weeks from admission date
The time taken to reach peak BEC after a severe exacerbation of COPD.
Time frame: 1, 2, 3, 4 and 6 weeks from admission date
Exploratory analysis looking for patient and treatment associations with rate of recovery of BEC.
Time frame: 1, 2, 3, 4 and 6 weeks from admission date
Comparison of the rate of recovery of BEC in patients who had further exacerbations of COPD within the study period and patients who have not had further exacerbations.
Time frame: 1, 2, 3, 4 and 6 weeks from admission date
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 14 Apr 2026.
- Background: PubMed 29331313Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
- Background: PubMed 35737975Singh D, Agusti A, Martinez FJ, Papi A, Pavord ID, Wedzicha JA, Vogelmeier CF, Halpin DMG. Blood Eosinophils and Chronic Obstructive Pulmonary Disease: A Global Initiative for Chronic Obstructive Lung Disease Science Committee 2022 Review. Am J Respir Crit Care Med. 2022 Jul 1;206(1):17-24. doi: 10.1164/rccm.202201-0209PP. No abstract available.
- Background: PubMed 28797382Suissa S, Ernst P. Precision Medicine Urgency: The Case of Inhaled Corticosteroids in COPD. Chest. 2017 Aug;152(2):227-231. doi: 10.1016/j.chest.2017.05.020. No abstract available.
- BackgroundGlobal Strategy for Prevention, Diagnosis and Management of COPD: 2023 Report. Global Initiative for Chronic Obstructive Lung Disease, 2023.
- Background: PubMed 22895999Steer J, Gibson J, Bourke SC. The DECAF Score: predicting hospital mortality in exacerbations of chronic obstructive pulmonary disease. Thorax. 2012 Nov;67(11):970-6. doi: 10.1136/thoraxjnl-2012-202103. Epub 2012 Aug 15.
- BackgroundPrasad A, Echevarria C, Steer J, Bourke S C. Blood eosinophil counts during severe exacerbations do not reflect stable state inflammatory phenotype in COPD. European Respiratory Journal 2022 60: 1870.
- Background: PubMed 29668352Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.
- Background: PubMed 32162970Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC.
- Background: PubMed 37487711Echevarria C, Steer J, Prasad A, Quint JK, Bourke SC. Admission blood eosinophil count, inpatient death and death at 1 year in exacerbating patients with COPD. Thorax. 2023 Nov;78(11):1090-1096. doi: 10.1136/thorax-2022-219463. Epub 2023 Jul 24.
- 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.
Peter Ireland, MBBS contact
Stephen Bourke, MBChB, PhD study chair
Northumbria Healthcare NHS Foundation Trust
Peter Ireland, MBBS principal investigator
Northumbria Healthcare NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
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 7 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 14 Apr 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 United Kingdom. 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.
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 Stephen Bourke, MBChB, PhD (0191 293 4351, stephen.bourke@nhct.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indices independently associated with eosinopenia on admission in patients with a severe exacerbation of COPD. (time frame: On admission date). The study lists 2 primary outcomes in all. 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 NCT06188065, which also lists 9 linked publications.
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 14 Apr 2026.