Trial Outcomes & Findings for Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial (NCT NCT04075331)
NCT ID: NCT04075331
Last Updated: 2026-04-24
Results Overview
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.
COMPLETED
PHASE2/PHASE3
238 participants
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).
2026-04-24
Participant Flow
Participant milestones
| Measure |
Placebo
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
119
|
|
Overall Study
COMPLETED
|
88
|
87
|
|
Overall Study
NOT COMPLETED
|
31
|
32
|
Reasons for withdrawal
| Measure |
Placebo
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
23
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
11
|
9
|
Baseline Characteristics
Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
Baseline characteristics by cohort
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=2 Participants
|
6 Participants
n=1 Participants
|
14 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
111 Participants
n=2 Participants
|
113 Participants
n=1 Participants
|
224 Participants
n=3 Participants
|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 9.1 • n=2 Participants
|
69.5 years
STANDARD_DEVIATION 8.9 • n=1 Participants
|
69.1 years
STANDARD_DEVIATION 9.0 • n=3 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=2 Participants
|
61 Participants
n=1 Participants
|
121 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=2 Participants
|
58 Participants
n=1 Participants
|
117 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
117 Participants
n=2 Participants
|
119 Participants
n=1 Participants
|
236 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
|
2 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
United Kingdom
|
119 participants
n=2 Participants
|
119 participants
n=1 Participants
|
238 participants
n=3 Participants
|
|
eMRC score
eMRC score≤3
|
39 Participants
n=2 Participants
|
39 Participants
n=1 Participants
|
78 Participants
n=3 Participants
|
|
eMRC score
eMRC score>3
|
80 Participants
n=2 Participants
|
80 Participants
n=1 Participants
|
160 Participants
n=3 Participants
|
|
Past hospitalisation in previous 12 months
No hospitalisation
|
39 Participants
n=2 Participants
|
40 Participants
n=1 Participants
|
79 Participants
n=3 Participants
|
|
Past hospitalisation in previous 12 months
≥1 hospitalised
|
80 Participants
n=2 Participants
|
79 Participants
n=1 Participants
|
159 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Time From Randomisation to Next Hospital Readmission or Death (All Cause)
|
25.7 Weeks
Interval 20.1 to 39.0
|
24.4 Weeks
Interval 17.9 to 33.0
|
SECONDARY outcome
Timeframe: 0-48 weeksPopulation: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=110 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Total Number of Hospital Readmissions All Cause Over 48 Weeks
|
1.77 Hospital readmission
Standard Deviation 2.88
|
1.54 Hospital readmission
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Total Number of Moderate Exacerbations Over 48 Weeks
|
2.22 Moderate exacerbations
Standard Deviation 2.24
|
1.83 Moderate exacerbations
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Total Number of Severe Exacerbations Over 48 Weeks
|
1.20 Severe exacerbations
Standard Deviation 2.36
|
0.91 Severe exacerbations
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Modified ITT (available data)
The number of exacerbations each participant had over the course of 48 (truncated follow-up minimum 24) weeks were calculated.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Total Number of Exacerbations Over 48 Weeks
|
3.42 Total exacerbations
Standard Deviation 3.08
|
2.74 Total exacerbations
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: 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).Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Time From Randomisation to Next Hospital Readmission or Death Due to a Respiratory Cause
|
24.4 Weeks
Interval 17.9 to 33.0
|
25.7 Weeks
Interval 20.1 to 39.0
|
SECONDARY outcome
Timeframe: 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).Population: Modified ITT (available data)
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)
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Time From Randomisation to Treatment Failure
|
10.0 Weeks
Interval 7.71 to 12.6
|
12.9 Weeks
Interval 10.1 to 15.7
|
SECONDARY outcome
Timeframe: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Hospital Readmission (Respiratory Cause)
|
55 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 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).Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Time From Randomisation to Next Hospital Readmission (All Cause)
|
27.9 Weeks
Interval 20.4 to 40.9
|
24.4 Weeks
Interval 17.9 to 33.0
|
SECONDARY outcome
Timeframe: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).Population: Modified ITT (available data)
All cause death. Number of individuals that died during follow up is reported. Death was analysed as a time to event outcome.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Death (All Cause)
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Patients were followed up for up to 48 weeks (48 week visit had a window of +/- 1 week).Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=119 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Death (Respiratory Cause)
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=109 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=106 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Extended Medical Research Council Dyspnoea Score (eMRC)
Week-0
|
5.0 score on a scale
Interval 4.0 to 5.0
|
5.0 score on a scale
Interval 5.0 to 5.0
|
|
Extended Medical Research Council Dyspnoea Score (eMRC)
Week-4
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
|
Extended Medical Research Council Dyspnoea Score (eMRC)
Week-8
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
|
Extended Medical Research Council Dyspnoea Score (eMRC)
Week-12
|
4.0 score on a scale
Interval 3.0 to 4.5
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Extended Medical Research Council Dyspnoea Score (eMRC)
Week-24
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
|
Extended Medical Research Council Dyspnoea Score (eMRC)
Week-36
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 4.0
|
|
Extended Medical Research Council Dyspnoea Score (eMRC)
Week-48
|
4.0 score on a scale
Interval 3.0 to 4.0
|
4.0 score on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=117 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=111 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
St George's Respiratory Questionnaire (SGRQ)
Week 12
|
63.3 Scores on a scale
Standard Deviation 16.3
|
64.3 Scores on a scale
Standard Deviation 16.4
|
|
St George's Respiratory Questionnaire (SGRQ)
Week 24
|
61.7 Scores on a scale
Standard Deviation 18.2
|
64.3 Scores on a scale
Standard Deviation 18.0
|
|
St George's Respiratory Questionnaire (SGRQ)
Week 36
|
60.4 Scores on a scale
Standard Deviation 20.0
|
61.2 Scores on a scale
Standard Deviation 18.1
|
|
St George's Respiratory Questionnaire (SGRQ)
Week 48
|
62.4 Scores on a scale
Standard Deviation 18.9
|
60.7 Scores on a scale
Standard Deviation 19.1
|
|
St George's Respiratory Questionnaire (SGRQ)
Baseline
|
72.0 Scores on a scale
Standard Deviation 13.8
|
69.8 Scores on a scale
Standard Deviation 15.7
|
|
St George's Respiratory Questionnaire (SGRQ)
Week 4
|
66.2 Scores on a scale
Standard Deviation 16.4
|
65.5 Scores on a scale
Standard Deviation 16.0
|
|
St George's Respiratory Questionnaire (SGRQ)
Week 8
|
64.6 Scores on a scale
Standard Deviation 18.1
|
64.3 Scores on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=117 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
COPD Assessment Tool (CAT)
Baseline
|
26.1 score on a scale
Standard Deviation 6.1
|
25.2 score on a scale
Standard Deviation 6.2
|
|
COPD Assessment Tool (CAT)
Week 4
|
23.9 score on a scale
Standard Deviation 6.2
|
22.3 score on a scale
Standard Deviation 6.6
|
|
COPD Assessment Tool (CAT)
Week 8
|
23.8 score on a scale
Standard Deviation 7.1
|
23.6 score on a scale
Standard Deviation 6.4
|
|
COPD Assessment Tool (CAT)
Week 12
|
23.0 score on a scale
Standard Deviation 7.7
|
23.6 score on a scale
Standard Deviation 6.6
|
|
COPD Assessment Tool (CAT)
Week 24
|
23.4 score on a scale
Standard Deviation 7.6
|
23.5 score on a scale
Standard Deviation 6.8
|
|
COPD Assessment Tool (CAT)
Week 36
|
22.5 score on a scale
Standard Deviation 8.4
|
22.8 score on a scale
Standard Deviation 7.3
|
|
COPD Assessment Tool (CAT)
Week 48
|
24.0 score on a scale
Standard Deviation 7.4
|
22.3 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=116 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Baseline
|
41.2 score on a scale
Standard Deviation 9.2
|
42.9 score on a scale
Standard Deviation 10.4
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Week 4
|
43.3 score on a scale
Standard Deviation 10.0
|
44.9 score on a scale
Standard Deviation 11.7
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Week 8
|
43.2 score on a scale
Standard Deviation 10.2
|
44.7 score on a scale
Standard Deviation 11.6
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
week 12
|
45.2 score on a scale
Standard Deviation 10.0
|
45.0 score on a scale
Standard Deviation 11.9
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Week 24
|
45.0 score on a scale
Standard Deviation 10.8
|
44.5 score on a scale
Standard Deviation 12.3
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Week 36
|
47.0 score on a scale
Standard Deviation 9.4
|
48.4 score on a scale
Standard Deviation 11.0
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Week 48
|
46.6 score on a scale
Standard Deviation 9.4
|
47.6 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=117 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
London Chest Activities of Daily Living Questionnaire (LCADL)
Baseline
|
28.9 score on a scale
Standard Deviation 10.8
|
27.6 score on a scale
Standard Deviation 11.3
|
|
London Chest Activities of Daily Living Questionnaire (LCADL)
Week 4
|
26.5 score on a scale
Standard Deviation 11.8
|
24.7 score on a scale
Standard Deviation 11.2
|
|
London Chest Activities of Daily Living Questionnaire (LCADL)
Week 8
|
24.8 score on a scale
Standard Deviation 12.3
|
24.6 score on a scale
Standard Deviation 10.2
|
|
London Chest Activities of Daily Living Questionnaire (LCADL)
Week 12
|
26.2 score on a scale
Standard Deviation 12.3
|
24.3 score on a scale
Standard Deviation 10.7
|
|
London Chest Activities of Daily Living Questionnaire (LCADL)
Week 24
|
25.2 score on a scale
Standard Deviation 12.0
|
24.6 score on a scale
Standard Deviation 12.1
|
|
London Chest Activities of Daily Living Questionnaire (LCADL)
Week 36
|
24.4 score on a scale
Standard Deviation 12.4
|
22.8 score on a scale
Standard Deviation 12.2
|
|
London Chest Activities of Daily Living Questionnaire (LCADL)
Week 48
|
26.4 score on a scale
Standard Deviation 12.9
|
23.6 score on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=118 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=117 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Baseline
|
7.0 SPPB total score
Interval 5.0 to 9.0
|
7.0 SPPB total score
Interval 5.0 to 9.0
|
|
Short Physical Performance Battery (SPPB)
Week 4
|
7.0 SPPB total score
Interval 6.0 to 9.0
|
8.5 SPPB total score
Interval 6.5 to 10.0
|
|
Short Physical Performance Battery (SPPB)
Week 8
|
8.0 SPPB total score
Interval 6.0 to 9.0
|
8.0 SPPB total score
Interval 6.0 to 11.0
|
|
Short Physical Performance Battery (SPPB)
Week 12
|
8.0 SPPB total score
Interval 6.0 to 10.0
|
9.0 SPPB total score
Interval 6.0 to 11.0
|
|
Short Physical Performance Battery (SPPB)
Week 24
|
7.5 SPPB total score
Interval 6.0 to 10.0
|
9.0 SPPB total score
Interval 6.0 to 10.0
|
|
Short Physical Performance Battery (SPPB)
Week 36
|
8.0 SPPB total score
Interval 6.0 to 10.0
|
9.0 SPPB total score
Interval 6.0 to 11.0
|
|
Short Physical Performance Battery (SPPB)
Week 48
|
8.0 SPPB total score
Interval 6.0 to 11.0
|
9.0 SPPB total score
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
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.
Outcome measures
| Measure |
Placebo
n=114 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=115 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Handgrip Strength
Week 12
|
25.0 Kilograms
Standard Deviation 9.8
|
27.8 Kilograms
Standard Deviation 9.6
|
|
Handgrip Strength
Week 24
|
26.6 Kilograms
Standard Deviation 9.8
|
28.3 Kilograms
Standard Deviation 10.0
|
|
Handgrip Strength
Week 36
|
26.8 Kilograms
Standard Deviation 10.1
|
28.4 Kilograms
Standard Deviation 11.0
|
|
Handgrip Strength
Week 48
|
26.7 Kilograms
Standard Deviation 10.3
|
28.4 Kilograms
Standard Deviation 10.7
|
|
Handgrip Strength
week 8
|
25.1 Kilograms
Standard Deviation 8.9
|
27.4 Kilograms
Standard Deviation 9.6
|
|
Handgrip Strength
Baseline
|
24.9 Kilograms
Standard Deviation 9.3
|
27.3 Kilograms
Standard Deviation 9.0
|
|
Handgrip Strength
Week 4
|
25.6 Kilograms
Standard Deviation 9.1
|
27.6 Kilograms
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT (available data)
The sputum eosinophil count (percentage) is defined as a continuous outcome that is expressed as a percentage.
Outcome measures
| Measure |
Placebo
n=45 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=38 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Baseline
|
0.68 Percentage of sputum eosinophil count
Standard Error 0.224
|
0.75 Percentage of sputum eosinophil count
Standard Error 0.235
|
|
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Week 4
|
0.84 Percentage of sputum eosinophil count
Standard Error 0.182
|
0.47 Percentage of sputum eosinophil count
Standard Error 0.216
|
|
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Week 8
|
0.90 Percentage of sputum eosinophil count
Standard Error 0.219
|
0.48 Percentage of sputum eosinophil count
Standard Error 0.244
|
|
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Week 12
|
0.70 Percentage of sputum eosinophil count
Standard Error 0.198
|
0.75 Percentage of sputum eosinophil count
Standard Error 0.245
|
|
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Week 24
|
0.91 Percentage of sputum eosinophil count
Standard Error 0.215
|
0.45 Percentage of sputum eosinophil count
Standard Error 0.256
|
|
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Week 36
|
0.56 Percentage of sputum eosinophil count
Standard Error 0.187
|
0.43 Percentage of sputum eosinophil count
Standard Error 0.220
|
|
Percentage Sputum Eosinophil Count (Inflammatory Markers)
Week 48
|
0.69 Percentage of sputum eosinophil count
Standard Error 0.210
|
0.51 Percentage of sputum eosinophil count
Standard Error 0.231
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 24, 36, 48Population: Modified ITT population
The serum eosinophil count is defined as a continuous outcome that is measured in cells/mL.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Total Serum Eosinophil Count (Inflammatory Markers)
Baseline
|
0.13 cells/mL
Standard Error 0.102
|
0.15 cells/mL
Standard Error 0.102
|
|
Total Serum Eosinophil Count (Inflammatory Markers)
Week 4
|
0.24 cells/mL
Standard Error 0.065
|
0.08 cells/mL
Standard Error 0.066
|
|
Total Serum Eosinophil Count (Inflammatory Markers)
Week 8
|
0.28 cells/mL
Standard Error 0.067
|
0.07 cells/mL
Standard Error 0.066
|
|
Total Serum Eosinophil Count (Inflammatory Markers)
Week 12
|
0.27 cells/mL
Standard Error 0.063
|
0.07 cells/mL
Standard Error 0.065
|
|
Total Serum Eosinophil Count (Inflammatory Markers)
Week 24
|
0.25 cells/mL
Standard Error 0.067
|
0.08 cells/mL
Standard Error 0.069
|
|
Total Serum Eosinophil Count (Inflammatory Markers)
Week 36
|
0.26 cells/mL
Standard Error 0.062
|
0.07 cells/mL
Standard Error 0.065
|
|
Total Serum Eosinophil Count (Inflammatory Markers)
Week 48
|
0.24 cells/mL
Standard Error 0.084
|
0.07 cells/mL
Standard Error 0.087
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: 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.
Adverse Event Rate in the 48 Weeks of the Trial From First Dose
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Adverse Events (AEs)
Randomised participants with Adverse Events
|
91 Participants
|
91 Participants
|
|
Adverse Events (AEs)
No Adverse Events
|
28 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: 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.
Serious adverse event rate over 48 week.
Outcome measures
| Measure |
Placebo
n=119 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Serious Adverse Events (SAEs)
Randomised participants with Serious Adverse Events
|
3 Participants
|
2 Participants
|
|
Serious Adverse Events (SAEs)
No Serious Adverse Events
|
116 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: Over 48 weeksPopulation: Modified ITT population
Blood pressure are defined as continuous outcomes that are measured in mmHg and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=117 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Pre Dose Systolic Blood Pressure (mmHg)
|
130.2 mmHg
Standard Deviation 19.4
|
129.7 mmHg
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: Over 48 weeksPopulation: Modified ITT population
Blood pressure are defined as continuous outcomes that are measured in mmHg and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=118 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=117 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Post Dose Systolic Blood Pressure (mmHg)
|
128.1 mmHg
Standard Deviation 19.6
|
127.4 mmHg
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: Over 48 weeksPopulation: Modified ITT population
Pre and post dose blood pressure are defined as continuous outcomes that are measured mmHg and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=117 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Pre Dose Diastolic Blood Pressure (mmHg)
|
73.2 mmHg
Standard Deviation 13.2
|
73.1 mmHg
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Over 48 weeksPopulation: Modified ITT population
Pre and post dose blood pressure are defined as continuous outcomes that are measured mmHg and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=117 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=117 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Post Dose Diastolic Blood Pressure (mmHg)
|
71.9 mmHg
Standard Deviation 13.4
|
72.3 mmHg
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Over 48 weeksPre and post dose heart rate are defined as continuous outcomes that are measured beats per minute (bpm) and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=117 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Pre Dose Heart Rate (Beats Per Minute)
|
81.4 bpm
Standard Deviation 14.1
|
81.8 bpm
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Over 48 weeksPre and post dose heart rate are defined as continuous outcomes that are measured beats per minute (bpm) and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=117 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=117 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Post Dose Heart Rate (Beats Per Minute)
|
79.8 bpm
Standard Deviation 14.4
|
79.6 bpm
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Over 48 weeksPopulation: Modified ITT population
Pre and post dose temperature are defined as continuous outcomes that are measured in °C and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=117 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Pre Dose Temperature (°C)
|
36.4 °C
Standard Deviation 0.4
|
36.4 °C
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Over 48 weeksPopulation: Modified ITT population
Pre and post dose temperature are defined as continuous outcomes that are measured in °C and reported as mean over 48 weeks.
Outcome measures
| Measure |
Placebo
n=115 Participants
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=117 Participants
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Post Dose Temperature (°C)
|
36.5 °C
Standard Deviation 0.4
|
36.5 °C
Standard Deviation 0.4
|
Adverse Events
Placebo
Mepolizumab
Serious adverse events
| Measure |
Placebo
n=119 participants at risk
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 participants at risk
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/119 • 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.
|
0.85%
1/118 • Number of events 1 • 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.
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/119 • 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.
|
0.85%
1/118 • Number of events 1 • 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.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.84%
1/119 • Number of events 1 • 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.
|
0.00%
0/118 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Death due to COPD
|
1.7%
2/119 • Number of events 2 • 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.
|
0.00%
0/118 • 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.
|
Other adverse events
| Measure |
Placebo
n=119 participants at risk
Saline solution
Placebo: Saline solution for subcutaneous injection
|
Mepolizumab
n=118 participants at risk
Mepolizumab
Mepolizumab: Mepolizumab 100mg subcutaneous injection
|
|---|---|---|
|
Investigations
Liver function test abnormal
|
1.7%
2/119 • Number of events 3 • 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.
|
5.1%
6/118 • Number of events 6 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
7.6%
9/119 • Number of events 11 • 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.
|
6.8%
8/118 • Number of events 10 • 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.
|
|
General disorders
Chest pain
|
4.2%
5/119 • Number of events 5 • 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.
|
5.1%
6/118 • Number of events 6 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.6%
9/119 • Number of events 11 • 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.
|
10.2%
12/118 • Number of events 20 • 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.
|
|
Infections and infestations
COVID-19
|
5.9%
7/119 • Number of events 7 • 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.
|
6.8%
8/118 • Number of events 8 • 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.
|
Additional Information
Professor Chris Brightling
Department of Respiratory Sciences, LE3 9QP, Leicester, UK
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place