A Phase 3 interventional study of Mepolizumab and placebo in Chronic Obstructive Pulmonary Diseases, Chronic Airways Limitation and Bronchitis, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by McMaster University · Phase 3, Interventional, and Treatment
Some patients with chronic obstructive pulmonary diseases (COPD) have large number of specific white blood cells called eosinophils in their airways. These cells are also responsible for causing episodes of worsened respiratory symptoms (exacerbations) and often cause irreversible damage to the airways . This subset of COPD patients often require oral steroids to bring down the number of eosinophils in their airways. Steroids have harmful effects on several of our body systems like bones, blood pressure, blood glucose control and can cause recurrent infections. Mepolizumab is a drug that specifically targets eosinophils reducing the number in the airway. This drug has been shown to be effective in decreasing exacerbation rates and time to exacerbation in asthma patients with eosinophils in their airways. Targeting eosinophils in COPD patients has been shown to reduce severe exacerbations. Hence it is likely that COPD patients with eosinophils in their airways will benefit similarly and have reduced rates and time to exacerbation.
Study Hypothesis:Does mepolizumab decrease sputum eosinophils in patients with fixed airflow obstruction (COPD) and eosinophilic bronchitis?
It is thus likely that a specific treatment such as anti-IL5 directed against eosinophils would be superior to the current standard treatment in decreasing sputum eosinophil counts and exacerbations and decrease structural changes (remodelling) in patients with COPD who continue to have eosinophils in their airway and whose airway disease has an eosinophil-driven component as evidenced by persistent airway eosinophilia.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 18 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Mepolizumab
Drug: placebo
This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.
Also known as: SB-240563
The placebo will consist of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).
Also known as: Normal saline
Percentage Decrease of Sputum Eosinophils From Baseline to End of Therapy (6 Months)
The results will be expressed as absolute changes in percent sputum eosinophil counts from baseline to end of therapy (at 6 months). Change is difference in sputum eosinophils between baseline/time zero to end of therapy/6 months. A larger number represents a greater degree in the reduction of sputum eosinophils.
Time frame: 6 months
Proportion of Patients With a Major Exacerbation.
Exacerbation: a sustained worsening of the patient's respiratory condition, from the stable state and beyond normal day-to-day variations, necessitating a change in regular medication in a patient with underlying COPD Major exacerbation will be defined as a symptomatic deterioration requiring treatment with antibiotics, oral or intravenous corticosteroids, hospitalization, or a combination of these.
Time frame: Baseline to 6 months
Patients who met eligibility criteria after the screening visit entered a 24 week double-blind treatment period followed by one follow-up visit.
| Milestone | Mepolizumab | Placebo |
|---|---|---|
| Started | 8 | 10 |
| Completed | 8 | 9 |
| Not completed | 0 | 1 |
The results will be expressed as absolute changes in percent sputum eosinophil counts from baseline to end of therapy (at 6 months). Change is difference in sputum eosinophils between baseline/time zero to end of therapy/6 months. A larger number represents a greater degree in the reduction of sputum eosinophils.
| percentage | Mepolizumab | Placebo |
|---|---|---|
| Percentage Decrease of Sputum Eosinophils From Baseline to End of Therapy (6 Months) | 11.28 ± 6.60 | 7.07 ± 11.49 |
Exacerbation: a sustained worsening of the patient's respiratory condition, from the stable state and beyond normal day-to-day variations, necessitating a change in regular medication in a patient with underlying COPD Major exacerbation will be defined as a symptomatic deterioration requiring treatment with antibiotics, oral or intravenous corticosteroids, hospitalization, or a combination of these.
| participants | Mepolizumab | Placebo |
|---|---|---|
| Proportion of Patients With a Major Exacerbation. | 4 | 7 |
Collected over Adverse events (AEs), including Serious adverse events (SAEs), in the on-study period were defined as those with onset between day of the first dose of study treatment (Day 0) and last scheduled follow-up visit, 4 months following final infusion (10 months).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mepolizumab | 0/8 (0%) | 2/8 (25%) | 4/8 (50%) |
| Placebo | 0/10 (0%) | 1/10 (10%) | 4/10 (40%) |
| Event | Mepolizumab | Placebo |
|---|---|---|
| Myocardial infarctionCardiac disorders | 1/8 | 0/10 |
| C3 distal humeral fracture with a left trochlear fractureMusculoskeletal and connective tissue disorders | 1/8 | 0/10 |
| COPD exacerbation - hospital admissionRespiratory, thoracic and mediastinal disorders | 0/8 | 1/10 |
| Event | Mepolizumab | Placebo |
|---|---|---|
| Infective bronchitisRespiratory, thoracic and mediastinal disorders | 3/8 | 4/10 |
| Urinary tract infectionRenal and urinary disorders | 1/8 | 0/10 |
| Age, Continuous(years) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Mean | 65 ± 6.31 | 67 ± 5.89 | 66 ± 5.97 |
| Sex: Female, Male(Participants) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 4 | 9 | 13 |
| Total cell count/g of sputum(cells per gram of sputum) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Median | 4.10 (0.90 to 33.10) | 11.6 (1.60 to 32.50) | 8.20 (0.9 to 33.10) |
| Sputum eosinophil count (%)(percentage of eosinophils) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Median | 11 (3.00 to 23.30) | 7.35 (3.70 to 37.70) | 10.10 (3.00 to 37.70) |
| Sputum neutrophil count (%)(percentage) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Mean | 54.5 ± 15.2 | 70.9 ± 15.7 | 63.6 ± 17.22 |
| Blood eosinophil count(cells/mm^3) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Mean | 0.69 ± 0.50 | 0.33 ± 0.29 | 0.5 ± 0.42 |
| Pre bronchodilator forced expiratory volume in 1 second (FEV1)(forced expiratory volume in litres) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Mean | 1.35 ± 0.49 | 0.99 ± 0.28 | 1.10 ± 0.42 |
| Pre bronchodilator FEV1%(percentage) | Mepolizumab | Placebo | Total |
|---|---|---|---|
| Median | 55.00 (29.00 to 69.00) | 29.50 (27.00 to 47.00) | 34.00 (27.00 to 69.00) |
13 further baseline measures are reported on the registry.
Plan to share: Undecided
The record gives a start of Jan 2012, a primary completion of Aug 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2025, 10 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mepolizumab
Pulmonary Disease, Chronic Obstructive →