NCT04075331.

Study name	Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial (COPD‐HELP)
Methods	Single‐centre, double‐blinded, randomised, placebo‐controlled trial Study location: Leicestershire, UK
Participants	Patients admitted to hospital for a severe exacerbation of eosinophilic COPD. Estimated enrolment: 238 participants Inclusion criteria: 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 ICS prior to this admission. Willing and able to consent to participate in trial. Able to understand written and spoken English. 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 NYHA Class IV heart failure. Decompensated liver disease or cirrhosis. Pregnant, breastfeeding, or lactating women. Women of childbearing 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 borne infection (e.g. HIV, hepatitis B or C).
Interventions	Mepolizumab 100 mg versus placebo Both mepolizumab and placebo are delivered SC. The placebo is saline solution for subcutaneous injection.
Outcomes	Primary outcome measure: Time from randomisation to next hospital readmission or death (all cause). Time Frame: 48 weeks Secondary outcome measures: Time from randomisation to first hospital readmission or death due to a respiratory cause. Time Frame: 48 weeks Total number of hospital readmissions all‐cause over 48 weeks. Time Frame: 48 weeks Total number of moderate exacerbations over 48 weeks. Time Frame: 48 weeks Time from randomisation to treatment failure. Time Frame: 48 weeks Time from randomisation to death (all‐cause). Time Frame: 48 weeks Time from randomisation to death (respiratory cause). Time Frame: 48 weeks Time from randomisation to first hospital readmission (all‐cause). Time Frame: 48 weeks Time from randomisation to first hospital readmission (respiratory cause). Time Frame: 48 weeks Length of index hospital admission. Time Frame: 48 weeks eMRC. Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 SGRQ. Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 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 Post‐bronchodilator lung function (FEV₁). Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 Post‐bronchodilator lung function (FVC). Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 Lung function (oscillometry). 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 Physical activity using accelerometry. Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 Handgrip strength. 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 Percentage sputum eosinophil count (inflammatory markers). Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 AEs. Time Frame: 48 weeks SAEs. Time Frame: 48 weeks Heart rate (bpm). Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 Blood pressure (systolic/diastolic mmHg). Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 Temperature (°C). Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Starting date	February 2020
Contact information	Neil Greening +44 (0)116 258 3474; neil.greening@leicester.ac.uk
Notes	Sponsor: University of Leicester. Collaborators: Leicester Clinical Trials Unit and GlaxoSmithKline