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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepolizumab | Experimental | Mepolizumab |
|
| Placebo | Placebo Comparator | Saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Drug | Mepolizumab 100mg subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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.
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).
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Brightling | University of Leicester | Study Chair |
| Neil Greening | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR Biomedical Research Centre, Respiratory | Leicester | Leicestershire | LE1 9QP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40305842 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Saline solution Placebo: Saline solution for subcutaneous injection |
| FG001 | Mepolizumab | Mepolizumab Mepolizumab: Mepolizumab 100mg subcutaneous injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Saline solution Placebo: Saline solution for subcutaneous injection |
| BG001 | Mepolizumab | Mepolizumab Mepolizumab: Mepolizumab 100mg subcutaneous injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis took place on the intention to treat population. All participants were included in the model. Where a participant did not experience an event during their follow-up period, they were censored at the last known follow-up assessment date. | Posted | Median | 95% Confidence Interval | Weeks | 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). |
|
Adverse events were collected for the duration of the study until the final trial visit (week 48/Final Follow-up) or 28 days post cessation of trial treatment where this occurs earlier than protocolised.
Participants were asked about AEs at each study visits and they were recorded on a participant specific AE log.
SAEs/SUSARs: reported to Sponsor and Leicester CTU within 24 hours of research staff learning of the event.
Adverse events were summarised on the safety population; All randomised participants excluding one participant who did not receive any dose in the Mepolizumab arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Saline solution Placebo: Saline solution for subcutaneous injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic aneurysm rupture | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver function test abnormal | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Chris Brightling | Department of Respiratory Sciences, LE3 9QP, Leicester, UK | +441162583656 | ceb17@leicester.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2024 | Jan 9, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2025 | Jan 9, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004802 | Eosinophilia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo |
| Drug |
Saline solution for subcutaneous injection |
|
|
| 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. |
| 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. | 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. | 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. | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Weeks 0, 4, 8, 12, 24, 36, 48 |
| Adverse Events (AEs) | Adverse Event Rate in the 48 Weeks of the Trial From First Dose | 48 weeks |
| Serious Adverse Events (SAEs) | Serious adverse event rate over 48 week. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Over 48 weeks |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| eMRC score | Stratification variable: scores >3 were considered to represent worse outcomes, with higher scores reflecting greater levels of breathlessness. | Count of Participants | Participants |
|
| Past hospitalisation in previous 12 months | Count of Participants | Participants |
|
| OG001 |
| Mepolizumab |
Mepolizumab Mepolizumab: Mepolizumab 100mg subcutaneous injection |
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | Hospital readmission | 0-48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | Moderate exacerbations | 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | Severe exacerbations | 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | Total exacerbations | 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Median | 95% Confidence Interval | Weeks | 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 | 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) | Modified ITT (available data) | Posted | Median | 95% Confidence Interval | Weeks | 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 | 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. | Modified ITT (available data) | Posted | Number | Participants | Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week). |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Median | 95% Confidence Interval | Weeks | 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 | 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. | Modified ITT (available data) | Posted | Number | Participants | Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week). |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Number | Participants | Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week). |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Median | Inter-Quartile Range | score on a scale | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | score on a scale | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Median | Inter-Quartile Range | SPPB total score | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | 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. | Modified ITT (available data) | Posted | Mean | Standard Deviation | Kilograms | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | Percentage Sputum Eosinophil Count (Inflammatory Markers) | The sputum eosinophil count (percentage) is defined as a continuous outcome that is expressed as a percentage. | Modified ITT (available data) | Posted | Geometric Mean | Standard Error | Percentage of sputum eosinophil count | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | Total Serum Eosinophil Count (Inflammatory Markers) | The serum eosinophil count is defined as a continuous outcome that is measured in cells/mL. | Modified ITT population | Posted | Geometric Mean | Standard Error | cells/mL | Weeks 0, 4, 8, 12, 24, 36, 48 |
|
|
|
|
| Secondary | Adverse Events (AEs) | Adverse Event Rate in the 48 Weeks of the Trial From First Dose | Safety outcomes were analysed using the safety population. The safety population was comprised of the all individuals that received at least one injection of either the active dose or the placebo, with individuals that received any injections of the active dose being in the mepolizumab arm. | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
|
| Secondary | Serious Adverse Events (SAEs) | Serious adverse event rate over 48 week. | Safety outcomes were analysed using the safety population. The safety population was comprised of the all individuals that received at least one injection of either the active dose or the placebo, with individuals that received any injections of the active dose being in the mepolizumab arm. | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT population | Posted | Mean | Standard Deviation | mmHg | Over 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT population | Posted | Mean | Standard Deviation | mmHg | Over 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT population | Posted | Mean | Standard Deviation | mmHg | Over 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT population | Posted | Mean | Standard Deviation | mmHg | Over 48 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | bpm | Over 48 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | bpm | Over 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT population | Posted | Mean | Standard Deviation | °C | Over 48 weeks |
|
|
|
|
| Secondary | 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. | Modified ITT population | Posted | Mean | Standard Deviation | °C | Over 48 weeks |
|
|
|
|
| 11 |
| 119 |
| 3 |
| 119 |
| 27 |
| 119 |
| EG001 | Mepolizumab | Mepolizumab Mepolizumab: Mepolizumab 100mg subcutaneous injection | 9 | 119 | 2 | 118 | 34 | 118 |
| Congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
|
| Death due to COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Week-4 |
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| Week-8 |
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| Week-12 |
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| Week-24 |
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| Week-36 |
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| Week-48 |
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| Superiority |
Wilcoxon Rank sum test of eMRC dyspnoea Week 8 |
| Wilcoxon Rank sum test of eMRC dyspnoea Week 12 | Wilcoxon (Mann-Whitney) | 0.52 | Superiority |
| Wilcoxon Rank sum test of eMRC dyspnoea Week 24 | Wilcoxon (Mann-Whitney) | 0.55 | Superiority |
| Wilcoxon Rank sum test of eMRC dyspnoea Week 36 | Wilcoxon (Mann-Whitney) | 0.77 | Superiority |
| Wilcoxon Rank sum test of eMRC dyspnoea Week 48 | Wilcoxon (Mann-Whitney) | 0.32 | Superiority |
| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 4 |
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| Week 8 |
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| week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Superiority |
| Wilcoxon (Mann-Whitney) | 0.20 | Superiority |
| Wilcoxon (Mann-Whitney) | 0.30 | Superiority |
| Wilcoxon (Mann-Whitney) | 0.52 | Superiority |
| Week 4 |
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| week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 36 |
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| Week 48 |
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