New COPD treatment cuts hospital returns in severe cases
NCT ID NCT04075331
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a drug called mepolizumab, given after a severe COPD flare-up that required hospital care, could prevent future hospital stays or death. It involved 238 adults with eosinophilic COPD (a type with high levels of certain white blood cells). Participants received either mepolizumab or a placebo alongside standard care. The goal was to see if the drug could reduce the risk of another hospital visit or death over about a year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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238 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Jun 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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/μL 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. Exclusion Criteria: 1. COPD patients without eosinophilia (defined as persistently \< 300 cells/μL 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 first 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
NIHR Biomedical Research Centre, Respiratory
Leicester, Leicestershire, LE1 9QP, United Kingdom
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