Mepolizumab for COPD Hospital Eosinophilic admissions Pragmatic trial (COPD-HELP)

Phase 1

• Conditions: Eosinophilic Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; MedDRA version: 21.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-003924-35-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-06
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

1. Symptoms typical of COPD when stable (baseline eMRC dyspnoea grade 2 or more).
2. A clinician defined exacerbation of COPD requiring admission to hospital.
3. Serum eosinophil count of = 300 cells/microlitre either at time of admission or at any one time in the preceding 12 months.
4. Smoking pack years > 10 years.
5. Age = 40 years.
6. Established on inhaled corticosteroids (ICS) prior to this admission.
7. Willing and able to consent to participate in trial.
8. Able to understand written and spoken English.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 214

Exclusion Criteria

1. COPD patients without eosinophilia (defined as persistently < 300 cells/microlitre within the last 12 months).
2. Other conditions that may be the cause of eosinophilia (such as hypereosinophilic syndrome, eosinophilic granulomatosis, eosinophilic oesophagitis or parasitic infection).
3. Patients whose treatment is considered palliative (life expectancy < 6 months).
4. 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.
5. Known history of anaphylaxis or hypersensitivity to mepolizumab or any of the excipients (sucrose, sodium phosphate dibasic heptahydrate, polysorbate 80).
6. 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.
7. Decompensated liver disease or cirrhosis.
8. 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 dosing with randomised treatment.*
9. 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.
10. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the efficacy of mepolizumab initiated during hospitalisation on future hospital readmission or death (all cause) compared with placebo in severe exacerbations of eosinophilic COPD.;Secondary Objective: To assess the effects of mepolizumab on health status, well-being, exercise capacity, frailty, moderate exacerbations, healthcare usage and death compared with placebo in patients admitted to hospital with an eosinophilic exacerbation of COPD.;Primary end point(s): The primary outcome is the time from randomisation to next hospital readmission or death (all cause).;Timepoint(s) of evaluation of this end point: Time to event between first dose and first event, up to 48 weeks.