Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial

NCT04075331 | Completed Phase 2 Results DMC

• 1 other identifier: 0690
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Eosinophilia

Keywords

COPD; eosinophilia; Chronic Obstructive Pulmonary Disorder; Mepolizumab

Outcome Measures

Primary Outcomes (1)

• Time From Randomisation to Next Hospital Readmission or Death (All Cause)

  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.

  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).

Secondary Outcomes (29)

• Total Number of Hospital Readmissions All Cause Over 48 Weeks

  0-48 weeks

• Total Number of Moderate Exacerbations Over 48 Weeks

  48 weeks

• Total Number of Severe Exacerbations Over 48 Weeks

  48 weeks

• Total Number of Exacerbations Over 48 Weeks

  48 weeks

• Time From Randomisation to Next Hospital Readmission or Death Due to a Respiratory Cause

  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).

Study Arms (2)

Mepolizumab

EXPERIMENTAL

Mepolizumab

Drug: Mepolizumab

Placebo

PLACEBO COMPARATOR

Saline solution

Drug: Placebo

Interventions

Mepolizumab DRUG

Mepolizumab 100mg subcutaneous injection

Mepolizumab

Placebo DRUG

Saline solution for subcutaneous injection

Also known as: Saline solution

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.\*
• 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 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.

Sponsors & Collaborators

• University of Leicester: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

NIHR Biomedical Research Centre, Respiratory

Leicester, Leicestershire, LE1 9QP, United Kingdom

Location

Related Publications (1)

• Flynn CA, McAuley HJC, Elneima O, Aung HWW, Ibrahim W, Ward TJC, Bourne M, Thornton TD, Mistry V, Gilbert HR, Waheed G, Wright AKA, Evans RA, Steiner MC, Brookes CL, Brightling CE, Greening NJ. Mepolizumab for COPD with Eosinophilic Phenotype following Hospitalization. NEJM Evid. 2025 Jun;4(6):EVIDoa2500012. doi: 10.1056/EVIDoa2500012. Epub 2025 Apr 30.

  PMID: 40305842 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Eosinophilia

Interventions

mepolizumab; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Professor Chris Brightling
• Organization: Department of Respiratory Sciences, LE3 9QP, Leicester, UK

ceb17@leicester.ac.uk

+441162583656

Study Officials

• Christopher Brightling

  University of Leicester

  STUDY CHAIR

• Neil Greening

  University of Leicester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: August 30, 2019
• Study Start: September 7, 2020
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-01

Locations

GB (1)