Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial

Más betegség

• Other conditions that may be the cause of eosinophilia (such as hypereosinophilic syndrome, eosinophilic granulomatosis, eosinophilic oesophagitis or parasitic infection).
• 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.
• 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.
• 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.

Laborértékek

• Known history of anaphylaxis or hypersensitivity to mepolizumab or any of the excipients (sucrose, sodium phosphate dibasic heptahydrate, polysorbate 80).
• 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.\*

Egyéb

• COPD patients without eosinophilia (defined as persistently \< 300 cells/μL within the last 12 months).
• Patients whose treatment is considered palliative (life expectancy \< 6 months).
• 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.

• 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.