COPDPhase 2/3COPD-HELPNCT04075331
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
A Phase 2/3 study testing Mepolizumab in people with COPD and Eosinophilia, run by University of Leicester at 1 site in United Kingdom.
Trial summary
This is a single-centre, double-blinded, randomised, placebo controlled trial comparing mepolizumab 100mg versus placebo in patients with eosinophilic COPD, started following their index admission to hospital. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Eosinophilia
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2020to 21 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms typical of COPD when stable (baseline eMRC dyspnoea grade 2 or more).
- A clinician defined exacerbation of COPD requiring admission to hospital.
- Serum eosinophil count of ≥ 300 cells/μL either at time of admission or at any one time in the preceding 12 months.
- Smoking pack years ≥10 years.
- Age ≥ 40 years.
- Established on inhaled corticosteroids (ICS) prior to this admission.
- Willing and able to consent to participate in trial.
- Able to understand written and spoken English.
Who cannot join
- COPD patients without eosinophilia (defined as persistently < 300 cells/μL within the last 12 months).
- Other conditions that may be the cause of eosinophilia (such as hypereosinophilic syndrome, eosinophilic granulomatosis, eosinophilic oesophagitis or parasitic infection).
- Patients whose treatment is considered palliative (life expectancy < 6 months).
- Other respiratory conditions including active lung cancer, interstitial lung disease, primary pulmonary hypertension or any other conditions that in the view of the investigator will affect the trial.
- Known history of anaphylaxis or hypersensitivity to mepolizumab or any of the excipients (sucrose, sodium phosphate dibasic heptahydrate, polysorbate 80).
- Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina in the last 6 months, unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months and New York Heart Association (NYHA) Class IV heart failure.
Show all 11Show fewer
- Decompensated liver disease or cirrhosis.
- Pregnant, breastfeeding, or lactating women. Women of child-bearing potential must agree to use appropriate methods of birth control and have a negative blood serum pregnancy test performed after randomisation but prior to first dosing with randomised treatment.*
- Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives.
- Known blood born infection (e.g. HIV, hepatitis B or C).
- Women of child bearing potential (WOCBP) - A woman is defined as being of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Biomedical Research Centre, Respiratory
Leicester, Leicestershire, LE1 9QP
About this study
Official title: A Randomised Controlled Trial of Mepolizumab Initiated Following Admission to Hospital for a Severe Exacerbation of Eosinophilic COPD
This is a single-centre, double-blinded, randomised, placebo controlled trial comparing mepolizumab 100mg versus placebo in patients with eosinophilic COPD, started following their index admission to hospital.
Read the detailed description
Patients admitted to hospital with an exacerbation of COPD are at high risk of readmission, of which a proportion are driven by eosinophilic inflammation. Whilst oral corticosteroids are beneficial in exacerbations, a considerable proportion of patients experience treatment failure, with 50% of patients readmitted within 3 months (www.RCPLondon.ac.uk).
Therapy, such as mepolizumab, reduces eosinophil count and has been shown to reduce exacerbation frequency when given in the stable state in both eosinophilic asthma (Papi et al. 2018) and COPD (Yousef, in press).
The investigators hypothesise that starting mepolizumab at the time of a hospitalisation for an exacerbation of COPD in patients with significant eosinophilia will result in a reduction in readmission to hospital in a high risk population.
Therefore, 238 participants will be recruited over an 18-month period and will be randomised into a 48-week treatment period in which they will receive monthly subcutaneous injections of either 100 mg mepolizumab or placebo. Secondary outcomes will be measured at baseline (week 0), 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks.
- Conditions
- COPD, Eosinophilia
- Being tested
- Mepolizumab, Placebo
- Keywords
- COPD, eosinophilia, Chronic Obstructive Pulmonary Disorder, Mepolizumab
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Mepolizumab 100mg subcutaneous injection
PlaceboDrug
Also called Saline solution
Saline solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab | Experimental | Mepolizumab Receives: Drug: Mepolizumab |
| Placebo | Placebo comparator | Saline solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Randomisation to Next Hospital Readmission or Death (All Cause)
To evaluate the efficacy of mepolizumab initiated following hospitalisation on future hospital readmission or death (all cause) compared with placebo and standard medical therapy in severe exacerbations of eosinophilic COPD.
Measured: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +- 1 week).
Secondary outcomes (29)
Total Number of Hospital Readmissions All Cause Over 48 Weeks
The number of hospital readmissions (all cause) in total during the 48 (truncated follow-up minimum 24) weeks corresponding to each participant were calculated. Where no hospital admission have occurred a value of zero was derived.
Measured: 0-48 weeks
Total Number of Moderate Exacerbations Over 48 Weeks
The severity of a COPD exacerbation was deemed as "Moderate" if the participant required treatment with steroids or antibiotics and was not hospitalised .
The number of moderate exacerbations each participant had over the course of 48 (truncated follow-up minimum 24) weeks were calculated.
Measured: 48 weeks
Total Number of Severe Exacerbations Over 48 Weeks
The severity of a COPD exacerbation was deemed as "Severe" if the participant required hospitalisation.
The number of severe exacerbations each participant had over the course of 48 (truncated follow-up minimum 24) weeks were calculated.
Measured: 48 weeks
Total Number of Exacerbations Over 48 Weeks
The number of exacerbations each participant had over the course of 48 (truncated follow-up minimum 24) weeks were calculated.
Measured: 48 weeks
Time From Randomisation to Next Hospital Readmission or Death Due to a Respiratory Cause
The time from randomisation to next hospital readmission or death (due to a respiratory cause) is defined as a time to event outcome measured in days. The date of randomisation as well as the date of readmission or death due to respiratory causes (whichever occurs first) were used to calculate time to event. For participants not experiencing an event the time was calculated from randomisation until last known follow-up assessment event-free.
Measured: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +- 1 week).
Time From Randomisation to Treatment Failure
Treatment failure is defined as the composite of three endpoints: 1. treatment intensification with systemic corticosteroids and/or antibiotics for respiratory reasons; 2. step-up in hospital care for respiratory reasons including transfer to the intensive care unit or readmission; or 3. all-cause mortality)
Measured: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +- 1 week).
Hospital Readmission (Respiratory Cause)
Hospital readmission (respiratory cause). Number of individuals that readmitted during follow up is reported. Hospital readmission due to respiratory cause was analysed as a time to event outcome.
Measured: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).
Time From Randomisation to Next Hospital Readmission (All Cause)
The time from randomisation to next hospital readmission (all cause) is defined as a time to event outcome measured in days. The date of randomisation and the date of next hospital readmission following randomisation was used to calculate time to event. Where hospital readmission doesn't occur during follow-up, time was measured until the participant's last known follow-up assessment.
Measured: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +/- 1 week).
Death (All Cause)
All cause death. Number of individuals that died during follow up is reported. Death was analysed as a time to event outcome.
Measured: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).
Death (Respiratory Cause)
Respiratory cause death. Number of individuals that died during follow up is reported. Death due to respiratory cause was analysed as a time to event outcome.
Measured: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).
Extended Medical Research Council Dyspnoea Score (eMRC)
This scale measures perceived respiratory disability. Participants rate their grades of breathlessness on a scale of 1 (least) to 5 (worst). The extension divides the grade 5 rating into 'a' (independent) and 'b' (dependent) to establish dependence on others for washing and dressing.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
St George's Respiratory Questionnaire (SGRQ)
This 50-item questionnaire measures health status (quality of life) in patients with diseases of airway obstruction. Scores are broken down into three components 'symptoms', 'activity', 'impacts', and the total score is calculated by summing the weights to all the positive responses in each component. For each subscale and the total score, values range from 0 (no impairment) to 100 (maximum impairment). Higher values represent a worse outcome.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
COPD Assessment Tool (CAT)
The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to measure the impact of COPD on a person's life, and how this changes over time. Scores range from 0-40, with higher scores indicating greater impact of COPD on a patient's life.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
This scale measures mental wellbeing using a 14-item scale. The scoring range for each item is from 1 - 5 and the total score is from 14-70, with higher scores indicating better mental wellbeing.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
London Chest Activities of Daily Living Questionnaire (LCADL)
This 15-item questionnaire measures dyspnoea during routine daily activities in patients with COPD. It consists of four components: 'Self-care', 'household activities', 'Physical activity' and 'Leisure activities'. The questions in each of the four domains are scored as follows: 0 ("I wouldn't do it anyway"), 1 ("I do not get breathless"), 2 ("I get moderately breathless"), 3 ("I get very breathless"), 4 ("I have given this up") and 5 ("Someone else does this for me"). The LCADL total score sums all individual questions to give values in the range 0 to 75 (inclusive), with the highest score representing maximal disability.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
Short Physical Performance Battery (SPPB)
SPPB ranges from 0 (worst performance) to 12 (best performance). This outcome measures lower extremity function using tasks that are similar to daily activities and it examines 3 areas: static balance, gait speed and getting in and out of a chair. The limitations based on the SPPB cut-off scores are defined as follows: "Severe limitations" if score is between 0-3, "Moderate limitations" if score is between 4-6, "Mild limitations" if score is between 7-9 and "Minimal limitations" if score is between 10-12. Lower scores indicate greater impairment.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
Handgrip Strength
Handgrip strength is defined as a continuous outcome that measures the amount of static force that the hand can squeeze around a dynamometer. This outcome is measured in Kilograms.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
Percentage Sputum Eosinophil Count (Inflammatory Markers)
The sputum eosinophil count (percentage) is defined as a continuous outcome that is expressed as a percentage.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
Total Serum Eosinophil Count (Inflammatory Markers)
The serum eosinophil count is defined as a continuous outcome that is measured in cells/mL.
Measured: Weeks 0, 4, 8, 12, 24, 36, 48
Adverse Events (AEs)
Adverse Event Rate in the 48 Weeks of the Trial From First Dose
Measured: 48 weeks
Serious Adverse Events (SAEs)
Serious adverse event rate over 48 week.
Measured: 48 weeks
Pre Dose Systolic Blood Pressure (mmHg)
Blood pressure are defined as continuous outcomes that are measured in mmHg and reported as mean over 48 weeks.
Measured: Over 48 weeks
Post Dose Systolic Blood Pressure (mmHg)
Blood pressure are defined as continuous outcomes that are measured in mmHg and reported as mean over 48 weeks.
Measured: Over 48 weeks
Pre Dose Diastolic Blood Pressure (mmHg)
Pre and post dose blood pressure are defined as continuous outcomes that are measured mmHg and reported as mean over 48 weeks.
Measured: Over 48 weeks
Post Dose Diastolic Blood Pressure (mmHg)
Pre and post dose blood pressure are defined as continuous outcomes that are measured mmHg and reported as mean over 48 weeks.
Measured: Over 48 weeks
Pre Dose Heart Rate (Beats Per Minute)
Pre and post dose heart rate are defined as continuous outcomes that are measured beats per minute (bpm) and reported as mean over 48 weeks.
Measured: Over 48 weeks
Post Dose Heart Rate (Beats Per Minute)
Pre and post dose heart rate are defined as continuous outcomes that are measured beats per minute (bpm) and reported as mean over 48 weeks.
Measured: Over 48 weeks
Pre Dose Temperature (°C)
Pre and post dose temperature are defined as continuous outcomes that are measured in °C and reported as mean over 48 weeks.
Measured: Over 48 weeks
Post Dose Temperature (°C)
Pre and post dose temperature are defined as continuous outcomes that are measured in °C and reported as mean over 48 weeks.
Measured: Over 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start7 Sep 2020
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Christopher Brightling, Study chair, University of LeicesterNeil Greening, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075331
- Sponsor's protocol ID
- 0690
- Acronym
- COPD-HELP
- Status last verified
- Jan 2026
- First submitted
- 23 May 2019
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flynn CA, McAuley HJC, Elneima O, Aung HWW, Ibrahim W, Ward TJC, Bourne M, Thornton TD, Mistry V, Gilbert HR, Waheed G, Wright AKA, Evans RA, Steiner MC, Brookes CL, Brightling CE, Greening NJ. Mepolizumab for COPD with Eosinophilic Phenotype following Hospitalization. NEJM Evid. 2025 Jun;4(6):EVIDoa2500012. doi: 10.1056/EVIDoa2500012. Epub 2025 Apr 30.
PubMed 40305842
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Mepolizumab Initiated Following Admission to Hospital for a Severe Exacerbation of Eosinophilic COPD
- ClinicalTrials.gov ID
- NCT04075331
- Acronym / sponsor ID
- COPD-HELP / 0690
- Conditions
- COPD, Eosinophilia
- Keywords
- COPD, eosinophilia, Chronic Obstructive Pulmonary Disorder, Mepolizumab
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-centre, double-blinded, randomised, placebo controlled trial comparing mepolizumab 100mg versus placebo in patients with eosinophilic COPD, started following their index admission to hospital.
Detailed description
Patients admitted to hospital with an exacerbation of COPD are at high risk of readmission, of which a proportion are driven by eosinophilic inflammation. Whilst oral corticosteroids are beneficial in exacerbations, a considerable proportion of patients experience treatment failure, with 50% of patients readmitted within 3 months (www.RCPLondon.ac.uk).
Therapy, such as mepolizumab, reduces eosinophil count and has been shown to reduce exacerbation frequency when given in the stable state in both eosinophilic asthma (Papi et al. 2018) and COPD (Yousef, in press).
The investigators hypothesise that starting mepolizumab at the time of a hospitalisation for an exacerbation of COPD in patients with significant eosinophilia will result in a reduction in readmission to hospital in a high risk population.
Therefore, 238 participants will be recruited over an 18-month period and will be randomised into a 48-week treatment period in which they will receive monthly subcutaneous injections of either 100 mg mepolizumab or placebo. Secondary outcomes will be measured at baseline (week 0), 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab | Experimental | Drug: MepolizumabMepolizumab |
| Placebo | Placebo comparator | Drug: PlaceboSaline solution |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptoms typical of COPD when stable (baseline eMRC dyspnoea grade 2 or more).
- A clinician defined exacerbation of COPD requiring admission to hospital.
- Serum eosinophil count of ≥ 300 cells/μL either at time of admission or at any one time in the preceding 12 months.
- Smoking pack years ≥10 years.
- Age ≥ 40 years.
Key exclusion criteria (11 listed)
- COPD patients without eosinophilia (defined as persistently < 300 cells/μL within the last 12 months).
- Other conditions that may be the cause of eosinophilia (such as hypereosinophilic syndrome, eosinophilic granulomatosis, eosinophilic oesophagitis or parasitic infection).
- Patients whose treatment is considered palliative (life expectancy < 6 months).
- Other respiratory conditions including active lung cancer, interstitial lung disease, primary pulmonary hypertension or any other conditions that in the view of the investigator will affect the trial.
- Known history of anaphylaxis or hypersensitivity to mepolizumab or any of the excipients (sucrose, sodium phosphate dibasic heptahydrate, polysorbate 80).
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 |
|---|---|---|
| MepolizumabMepolizumab 100mg subcutaneous injection | Drug | Mepolizumab |
| PlaceboAlso: Saline solutionSaline solution for subcutaneous injection | Drug | Placebo |
Primary outcome
Time From Randomisation to Next Hospital Readmission or Death (All Cause)
Time frame: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +- 1 week).
To evaluate the efficacy of mepolizumab initiated following hospitalisation on future hospital readmission or death (all cause) compared with placebo and standard medical therapy in severe exacerbations of eosinophilic COPD.
29 secondary outcomes
Total Number of Hospital Readmissions All Cause Over 48 Weeks
Time frame: 0-48 weeks
Total Number of Moderate Exacerbations Over 48 Weeks
Time frame: 48 weeks
Total Number of Severe Exacerbations Over 48 Weeks
Time frame: 48 weeks
Total Number of Exacerbations Over 48 Weeks
Time frame: 48 weeks
Time From Randomisation to Next Hospital Readmission or Death Due to a Respiratory Cause
Time frame: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +- 1 week).
Time From Randomisation to Treatment Failure
Time frame: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +- 1 week).
Hospital Readmission (Respiratory Cause)
Time frame: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).
Time From Randomisation to Next Hospital Readmission (All Cause)
Time frame: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +/- 1 week).
Death (All Cause)
Time frame: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).
Death (Respiratory Cause)
Time frame: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).
Extended Medical Research Council Dyspnoea Score (eMRC)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
St George's Respiratory Questionnaire (SGRQ)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
COPD Assessment Tool (CAT)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
London Chest Activities of Daily Living Questionnaire (LCADL)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
Short Physical Performance Battery (SPPB)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
Handgrip Strength
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
Total Serum Eosinophil Count (Inflammatory Markers)
Time frame: Weeks 0, 4, 8, 12, 24, 36, 48
Adverse Events (AEs)
Time frame: 48 weeks
Serious Adverse Events (SAEs)
Time frame: 48 weeks
Pre Dose Systolic Blood Pressure (mmHg)
Time frame: Over 48 weeks
Post Dose Systolic Blood Pressure (mmHg)
Time frame: Over 48 weeks
Pre Dose Diastolic Blood Pressure (mmHg)
Time frame: Over 48 weeks
Post Dose Diastolic Blood Pressure (mmHg)
Time frame: Over 48 weeks
Pre Dose Heart Rate (Beats Per Minute)
Time frame: Over 48 weeks
Post Dose Heart Rate (Beats Per Minute)
Time frame: Over 48 weeks
Pre Dose Temperature (°C)
Time frame: Over 48 weeks
Post Dose Temperature (°C)
Time frame: Over 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40305842Flynn CA, McAuley HJC, Elneima O, Aung HWW, Ibrahim W, Ward TJC, Bourne M, Thornton TD, Mistry V, Gilbert HR, Waheed G, Wright AKA, Evans RA, Steiner MC, Brookes CL, Brightling CE, Greening NJ. Mepolizumab for COPD with Eosinophilic Phenotype following Hospitalization. NEJM Evid. 2025 Jun;4(6):EVIDoa2500012. doi: 10.1056/EVIDoa2500012. Epub 2025 Apr 30.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Christopher Brightling study chair
University of Leicester
Neil Greening principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mepolizumab in people with COPD and Eosinophilia, run by University of Leicester 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 24 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time From Randomisation to Next Hospital Readmission or Death (All Cause) (time frame: Patients were followed up for up to 48 weeks (an absolute maximum of 49 weeks as the 48 week visit had a visit window of +- 1 week).). 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 NCT04075331, which also lists 1 linked publication.
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 24 Apr 2026.