Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial
United Kingdom238 participantsStarted 2020-09-07
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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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 inhaled corticosteroids (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.
✕
What they're measuring
1
Time From Randomisation to Next Hospital Readmission or Death (All Cause)
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).
. 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.\*