COPDPhase 3SUMMERNCT05138250
A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD
A Phase 3 study testing Mepolizumab 100 MG in people with COPD, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators aim to recruit 32 people with COPD who have frequent exacerbations and high eosinophil counts which indicates "asthmatic type" inflammation and treat them for a year with mepolizumab. This is a licenced medication for asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Mepolizumab 100 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2022to 8 May 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD as determined by a post bronchodilator FEV1/FVC <70% and an FEV1 of between 20 and 80% at screening visit
- Treatment with inhaled triple therapy (licensed combination of long acting beta 2 agonist, long acting anti-muscarinic and corticosteroid) at constant dose for at least 12 weeks before screening visit. Treatment with roflumilast, theophyillines and macrolides will be permitted so long as they were introduced at stable dose > 12 weeks prior to screening visit. (If maintenance drug dosing has not been with stable dosages for 12 weeks the screening visit may be rescheduled until this is achieved: see sections 7.3 and 7.10)
- At least 2 acute exacerbations of COPD (AECOPD) requiring treatment with oral steroids and/or antibiotics in the last 12 months, or 1 acute AECOPD requiring hospital admission in the last 12 months.
- At least one eosinophil count of >0.3 cells·μL-1 in the 12 months prior to screening
- Age over 18 years
Who cannot join
- Contraindication to MRI scanning, including Gadovist (ie hypersensitivity or poor renal function; see below); this includes claustrophobia and musculoskeletal difficulties, this information is collected on the UoS MRI unit screening form.
- Inability to give informed consent or comply with study procedures
- Hypersensitivity to mepolizumab or its excipients
- Untreated helminthic infection
- Exacerbation of COPD requiring treatment with oral steroids and/or antibiotics within 4 weeks of screening. A repeat screening visit may be scheduled in order to achieve this criterion. The participant will be required to successfully complete all screening procedures at the rescheduled visit, including that for exacerbation-free stability.
- SpO2 <90% on room air at screening
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- Clear history of childhood and/or current asthma
- Past history of lung surgery
- Other significant lung disease
- Long term oral steroid treatment
- eGFR < 30 ml/min/1.73 m2 at screening
- NYHA class 3 or 4, where the functional limitation from heart disease is greater than that from COPD, or uncompensated heart failure
- Chronic liver disease (Any elevation of ALT above twice the upper limit of normal at screening. Lower levels of abnormality are permitted after investigator review if felt not to compromise safety)
- Malignancy unless treated and disease free for 5 years
- Conditions causing significant immunosuppression
- Active infection with blood borne viruses (including hepatitis A and B and HIV)
- Other significant medical condition compromising participant safety or fidelity of study.
- Pregnant or breast feeding
- Of childbearing potential and not willing to use highly effective methods of contraception during the course of the study and for 100 days post last dose of mepolizumab.
- Participants who have received an investigational drug within 30 days of first dose, or within 5 drug half-lives of the investigational drug, whichever is longer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility - NGH
Sheffield, S Yorkshire, S5 7AU
About this study
The investigators aim to recruit 32 people with COPD who have frequent exacerbations and high eosinophil counts which indicates "asthmatic type" inflammation and treat them for a year with mepolizumab. This is a licenced medication for asthma. Mepolizumab is a monoclonal antibody that acts through interleukin-5 (IL-5) antagonism to reduce blood eosinophil levels and is effective at reducing exacerbations in asthmatics. To determine whether mepolizumab may be an effective treatment in people with COPD and "asthmatic type" inflammation participants will have MRI scans before the treatment, after 12 weeks and after a year to see how the drug affects inflammation. The investigators will also compare our measurements with the number of exacerbations people get (measured by diaries), with measures of their quality of life (using a questionnaire), and with ordinary laboratory breathing tests. The investigators are especially interested to know if the reduction in inflammation early on after 12 weeks is associated with fewer exacerbations and better quality of life over the year.
- Conditions
- COPD
- Being tested
- Mepolizumab 100 MG
- Keywords
- MRI, eosinophil, exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab 100 MGDrug
participants will receive 100mg of mepolizumab every 4 weeks for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (all participants, not randomised) | Experimental | All participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses) Receives: Drug: Mepolizumab 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage Ventilated Defect Percent (VDP)
The within subject change in VDP assessed by XeMRI from baseline to 12 weeks of treatment with mepolizumab. Since the protocol was written, the convention has been to report ventilation defect, the percentage of lung that is not ventilated, rather than %VV, the percentage that is ventilated. A decrease in ventilation defect is an improvement in ventilation.
Measured: Baseline to 12 weeks of treatment
Change in Pulmonary Inflammation
The within participant change in membrane (M)/gas (the ratio of xenon dissolved in the alveolar membrane to gaseous xenon in the airspaces, a measure of alveolar membrane absorption) assessed by XeMRI from baseline to 12 weeks of mepolizumab as an index of pulmonary inflammation. M/gas is a measure of alveolar thickness, which is an index of pulmonary inflammation. An decrease in M/gas indicates reduced inflammation.
Measured: From Baseline to 12 weeks of treatment
Secondary outcomes (2)
Change in MRI Metrics in Low and High Exacerbation Groups - Longitudinal Relaxation Time (T1)
Comparison of change in MRI metrics (Longitudinal relaxation time (T1)) from baseline to 12 weeks in groups with a) low or b) high total 52 week exacerbation (groups defined by median split of total exacerbations over 52 weeks assessed by EXACT-Pro).
Longitudinal relaxation time (T1) is intrinsic MRI relaxation time affected by changes in tissue water content, this measure is expected to increase with inflammation.
Measured: From Baseline to 12 weeks of treatment
Change in MRI Metrics in Low and High Exacerbation Groups - M0
Comparison of change in MRI metrics (Proton spin density (M0)) from baseline to 12 weeks in groups with a) low or b) high total 52 week exacerbation (groups defined by median split of total exacerbations over 52 weeks assessed by EXACT-Pro).
Proton spin density (M0) is a measure of parenchymal density affected by changes in tissue water content, this measure is expected to increase with inflammation.
Measured: From Baseline to 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start8 May 2022
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Rod Lawson, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138250
- Sponsor's protocol ID
- STH21067
- Acronym
- SUMMER
- Status last verified
- May 2026
- First submitted
- 5 Nov 2021
- Last updated
- 7 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD
- ClinicalTrials.gov ID
- NCT05138250
- Acronym / sponsor ID
- SUMMER / STH21067
- Conditions
- COPD
- Keywords
- MRI, eosinophil, exacerbation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 8 May 2022 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Posted 7 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to recruit 32 people with COPD who have frequent exacerbations and high eosinophil counts which indicates "asthmatic type" inflammation and treat them for a year with mepolizumab. This is a licenced medication for asthma. Mepolizumab is a monoclonal antibody that acts through interleukin-5 (IL-5) antagonism to reduce blood eosinophil levels and is effective at reducing exacerbations in asthmatics. To determine whether mepolizumab may be an effective treatment in people with COPD and "asthmatic type" inflammation participants will have MRI scans before the treatment, after 12 weeks and after a year to see how the drug affects inflammation. The investigators will also compare our measurements with the number of exacerbations people get (measured by diaries), with measures of their quality of life (using a questionnaire), and with ordinary laboratory breathing tests. The investigators are especially interested to know if the reduction in inflammation early on after 12 weeks is associated with fewer exacerbations and better quality of life over the year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (all participants, not randomised) | Experimental | Drug: Mepolizumab 100 MGAll participants will be treated with mepolizumab, a 100mg dose every 4 weeks for 1 year (13 doses) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of COPD as determined by a post bronchodilator FEV1/FVC <70% and an FEV1 of between 20 and 80% at screening visit
- Treatment with inhaled triple therapy (licensed combination of long acting beta 2 agonist, long acting anti-muscarinic and corticosteroid) at constant dose for at least 12 weeks before screening visit. Treatment with roflumilast, theophyillines and macrolides will be permitted so long as they were introduced at stable dose > 12 weeks prior to screening visit. (If maintenance drug dosing has not been with stable dosages for 12 weeks the screening visit may be rescheduled until this is achieved: see sections 7.3 and 7.10)
- At least 2 acute exacerbations of COPD (AECOPD) requiring treatment with oral steroids and/or antibiotics in the last 12 months, or 1 acute AECOPD requiring hospital admission in the last 12 months.
- At least one eosinophil count of >0.3 cells·μL-1 in the 12 months prior to screening
- Age over 18 years
Key exclusion criteria (20 listed)
- Contraindication to MRI scanning, including Gadovist (ie hypersensitivity or poor renal function; see below); this includes claustrophobia and musculoskeletal difficulties, this information is collected on the UoS MRI unit screening form.
- Inability to give informed consent or comply with study procedures
- Hypersensitivity to mepolizumab or its excipients
- Untreated helminthic infection
- Exacerbation of COPD requiring treatment with oral steroids and/or antibiotics within 4 weeks of screening. A repeat screening visit may be scheduled in order to achieve this criterion. The participant will be required to successfully complete all screening procedures at the rescheduled visit, including that for exacerbation-free stability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepolizumab 100 MGparticipants will receive 100mg of mepolizumab every 4 weeks for 52 weeks | Drug | Treatment arm (all participants, not randomised) |
Primary outcome
Change in Percentage Ventilated Defect Percent (VDP)
Time frame: Baseline to 12 weeks of treatment
The within subject change in VDP assessed by XeMRI from baseline to 12 weeks of treatment with mepolizumab. Since the protocol was written, the convention has been to report ventilation defect, the percentage of lung that is not ventilated, rather than %VV, the percentage that is ventilated. A decrease in ventilation defect is an improvement in ventilation.
Change in Pulmonary Inflammation
Time frame: From Baseline to 12 weeks of treatment
The within participant change in membrane (M)/gas (the ratio of xenon dissolved in the alveolar membrane to gaseous xenon in the airspaces, a measure of alveolar membrane absorption) assessed by XeMRI from baseline to 12 weeks of mepolizumab as an index of pulmonary inflammation. M/gas is a measure of alveolar thickness, which is an index of pulmonary inflammation. An decrease in M/gas indicates reduced inflammation.
2 secondary outcomes
Change in MRI Metrics in Low and High Exacerbation Groups - Longitudinal Relaxation Time (T1)
Time frame: From Baseline to 12 weeks of treatment
Change in MRI Metrics in Low and High Exacerbation Groups - M0
Time frame: From Baseline to 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rod Lawson principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mepolizumab 100 MG in people with COPD, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage Ventilated Defect Percent (VDP) (time frame: Baseline to 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.