AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT02105961

Efficacy and Safety of Mepolizumab as an Add-on Treatment in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Mepolizumab in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 169 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Mepolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
674 participants
Where
169 sitesin 15 countries
Study dates
24 Apr 2014to 16 Jan 2017
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COPD diagnosis: Subjects with a clinically documented history of COPD for at least 1 year in accordance with the following definition by the American Thoracic Society/European Respiratory Society
  • Severity of COPD: Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second/ Forced vital capacity (FEV1/FVC) ratio of <0.70 at Visit 1 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1> 20 percent and <=80 percent of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations at Visit 1
  • History of exacerbations: A well documented history (e.g., medical record verification) in the 12 months prior to Visit 1 of ; at least two moderate COPD exacerbations. Moderate is defined as the use of systemic corticosteroids (intramuscular (IM), intravenous, or oral) and/or treatment with antibiotics or; at least one severe COPD exacerbation. Severe is defined as having required hospitalization. Note: At least one exacerbation must have occurred while the subject was taking Inhaled corticosteroid (ICS) plus long acting beta2-agonist (LABA) plus long acting muscarinic antagonist (LAMA). Prior use of antibiotics alone does not qualify as a moderate exacerbation unless the use was specifically for the treatment of worsening symptoms of COPD.
  • Concomitant COPD therapy: A well documented requirement for optimized standard of care background therapy that includes Inhaled corticosteroid (ICS) plus 2 additional COPD medications (i.e., triple therapy) for the 12 months prior to Visit 1 and meets the following criteria: Immediately prior to Visit 1, minimum of 3 months of use of an; Inhaled corticosteroid at a dose >= 500 micrograms (mcg)/day fluticasone propionate dose equivalent plus; LABA and LAMA.
  • For subjects who are not continually maintained on ICS plus LABA plus LAMA for the entire 12 months prior to Visit 1 use of following is allowed (but not in the 3 months immediately prior to Visit 1); inhaled corticosteroid at a dose >=500 mcg/day fluticasone propionate dose equivalent plus; a LABA or a LAMA and; use of at least one other class of COPD medication (i.e., phosphodiesterase-4-inhibitors, methylxanthines, or a combination of short acting beta2-agonist and short acting muscarinic antagonist).
  • Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
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  • Gender: Male or Eligible Female; To be eligible for entry into the study females of child bearing potential must commit to consistent and correct use of an acceptable method of birth control from the time of consent, for the duration of the trial, and for 4 months after last study drug administration.
  • Age: At least 40 years of age at Visit 1
  • Smoking status: Subject with confirmed COPD are eligible to participate independent of their smoking status and smoking history, i.e. current smokers, never smokers or ex-smokers can be enrolled into the study. Current smokers are defined as those with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who meet the definition of a current smoker but have stopped smoking for at least 6 months prior to Visit 1. Never smokers are those that do not meet the definition of a current or former smoker.
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Subjects with Asthma: Current and Former Smokers: Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD); Never-Smokers: Subjects with any history of asthma.
  • Other respiratory disorders: The investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Subjects with alpha1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also, excluded are subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. Subjects are also excluded if maintenance use of bi-level positive airway pressure is required for the treatment of respiratory disorder.
  • COPD stability: Subjects with pneumonia, exacerbation, lower respiratory infection within the 4 weeks prior to Visit 1.
  • Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
  • Pulmonary rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
  • Oxygen: Subjects receiving treatment with oxygen more than 4.0 liters/minute (L/min). While breathing supplemental oxygen, subjects should demonstrate an oxyhemoglobin saturation greater than or equal to 89 percent.
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  • 12-lead Electrocardiography (ECG) finding: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1, if considered to be clinically significant by the Investigator. 12-lead ECGs will be over-read by a centralized independent cardiologist to assist in consistent evaluation of subject eligibility. Results from the 12-lead ECG over-read must be received prior to assessing eligibility at Visit 2.
  • Unstable or life threatening cardiac disease: Subjects with any of the following would be excluded: Myocardial infarction or unstable angina in the last 6 months ; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months ; New York Heart Association (NYHA) Class IV Heart failure
  • Other diseases/abnormalities: Subjects with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Eosinophilic disease: Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis (EGPA, also known as Churg-Strauss Syndrome), or Eosinophilic Esophagitis.
  • Parasitic infection: Subjects with a pre-existing helminthes infestation within 6 months prior to Visit 1 are also excluded.
  • Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (Subjects that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded). South Korea subjects with a diagnosis of malignancy within 5 years of Visit 1 are excluded.
  • Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids taken for COPD.
  • Liver disease: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria (e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of screening)
  • Monoclonal antibodies: Subjects who have received any monoclonal antibody within 5 half-lives of Visit 1.
  • Investigational medications: Subjects who have received an investigational drug within 30 days of Visit 1, or within 5 drug half-lives of the investigational drug, whichever is longer (this also includes investigational formulations of a marketed product).
  • Hypersensitivity: Subjects with a known allergy or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic
  • Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
  • Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
  • Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
  • Drug or alcohol abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Previous participation: Subjects who have previously participated in any study of mepolizumab.
  • Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
  • Randomization Criteria
  • In order to be randomized to study drug the subject must meet the following randomization criteria at Visit 2:
  • Blood eosinophils: Documented elevated peripheral blood eosinophil count of >=300 cells/microliter within the past 12 months prior to Visit 1; OR A peripheral baseline blood eosinophil count of >=150 cells/microliter from haematology conducted at Visit 1
  • Electronic Diary Compliance: Compliance with completion of the eDiary defined as completion of all questions on 5 or more days out of the 7 days immediately preceding Visit 2.
  • 12-lead ECG: No evidence of an abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1 as indicated on the over-read provided by the centralized independent cardiologist. Subjects with a QT interval corrected with Fridericia's formulas (QTcF)>=450 msec are not eligible. For subjects with a QRS interval >=120msec, those with QTcF>=480 msec are not eligible. Specific ECG findings that preclude subject eligibility are listed in the protocol.
  • Abnormal chest X-ray (or Computerized Tomography [CT] scan): No chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. If a chest X-ray or CT scan is not available within 6 months prior to Visit 1, then a chest X-ray must be taken at Visit 1 and the results reviewed prior to randomization. For sites in Germany: If a chest X-ray (or CT scan) within 6 months prior to Screening (Visit 1) is not available, the subject will not be eligible for the study.
  • Laboratory abnormality: No evidence of clinically significant abnormality in the haematological, biochemical, or urinalysis screen at Visit 1, as judged by the investigator.
  • Hepatitis B: Subjects who are HBsAg positive or HBcAb positive must not have a HBV DNA level >=2000 International Units (IU)/millilitre (mL).
  • Liver function test: Subjects must meet the following based on results from sample taken at Visit 1: Alanine aminotransferase (ALT) <2x ULN (upper limit of normal); Alkaline Phosphatase (Alk Phos) <=2x ULN; Bilirubin <=1.5x ULN (isolated bilirubin>1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent)
  • Pregnancy: No subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.

Trial locations and contacts

169 sites in 15 countries.

169 sites in 15 countries

United States35 sites

  • GSK Investigational Site

    Adairsville, Georgia, 30103

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Bowling Green, Kentucky, 42101

  • GSK Investigational Site

    Boynton Beach, Florida, 33436

  • GSK Investigational Site

    Broomfield, Colorado, 80023

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 43213

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Duluth, Georgia, 30096

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Edgewater, Florida, 32132

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Gainesville, Florida, 32608

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Huntersville, North Carolina, 28078

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Morgantown, West Virginia, 26505

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Oaks, Pennsylvania, 19456

  • GSK Investigational Site

    Orlando, Florida, 32825

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Portland, Oregon, 97220

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    St. Petersburg, Florida, 33704

  • GSK Investigational Site

    Stamford, Connecticut, 06902

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Woodstock, Georgia, 30189

Other trials in United States

Japan32 sites

  • GSK Investigational Site

    Ehime, 791-0281

  • GSK Investigational Site

    Fukui, 910-1193

  • GSK Investigational Site

    Fukuoka, 811-1394

  • GSK Investigational Site

    Fukushima, 960-1295

  • GSK Investigational Site

    Gifu, 509-6134

  • GSK Investigational Site

    Hiroshima, 722-8503

  • GSK Investigational Site

    Hiroshima, 734-8530

  • GSK Investigational Site

    Hokkaido, 053-8506

  • GSK Investigational Site

    Hyōgo, 650-0047

  • GSK Investigational Site

    Kagawa, 762-8550

  • GSK Investigational Site

    Kanagawa, 227-8501

  • GSK Investigational Site

    Kumamoto, 861-1196

  • GSK Investigational Site

    Mie, 515-8544

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Miyagi, 983-8520

  • GSK Investigational Site

    Miyagi, 986-8522

  • GSK Investigational Site

    Ōita, 876-0813

  • GSK Investigational Site

    Okayama, 702-8055

  • GSK Investigational Site

    Okayama, 711-0921

  • GSK Investigational Site

    Okinawa, 901-2121

  • GSK Investigational Site

    Osaka, 573-0153

  • GSK Investigational Site

    Osaka, 589-8511

  • GSK Investigational Site

    Osaka, 591-8555

  • GSK Investigational Site

    Shimane, 693-8501

  • GSK Investigational Site

    Shizuoka, 436-0022

  • GSK Investigational Site

    Shizuoka, 438-8550

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 104-8560

  • GSK Investigational Site

    Tokyo, 136-0075

  • GSK Investigational Site

    Tokyo, 142-8666

  • GSK Investigational Site

    Tokyo, 152-0021

  • GSK Investigational Site

    Tokyo, 204-8585

Other trials in Japan

Germany15 sites

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70378

Other trials in Germany

South Korea14 sites

  • GSK Investigational Site

    Anyang-Si Gyeonggi-do, 431-070

  • GSK Investigational Site

    Bucheon City, Gyenggi-do, 420-767

  • GSK Investigational Site

    Busan, 602-715

  • GSK Investigational Site

    Cheongju, Chungcheongbuk-do, 361-711

  • GSK Investigational Site

    Daegu, 705-703

  • GSK Investigational Site

    Incheon, 403-720

  • GSK Investigational Site

    Jeonju, 561-712

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 130-709

  • GSK Investigational Site

    Seoul, 130-872

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 140-743

  • GSK Investigational Site

    Seoul

  • GSK Investigational Site

    Wonju-si, Kanwon-do, 220-701

Other trials in South Korea

Netherlands10 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5223 GZ

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Groningen, 9713 GZ

  • GSK Investigational Site

    Hoofddorp, 2134 TM

  • GSK Investigational Site

    Horn, 6085 NM

  • GSK Investigational Site

    Leiden, 2333 ZA

  • GSK Investigational Site

    Sittard-geleen, 6162 BG

  • GSK Investigational Site

    Utrecht, 3584 CX

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Romania10 sites

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Codlea, 505100

  • GSK Investigational Site

    Craiova, 200642

  • GSK Investigational Site

    Focşani, 620043

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Piteşti, 110084

  • GSK Investigational Site

    Ploieşti, 100024

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Argentina9 sites

  • GSK Investigational Site

    Bahía Blanca, Buenos Aires, B8000AAK

  • GSK Investigational Site

    Berazategui, 1886

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF

  • GSK Investigational Site

    La Plata, Buenos Aires, 1900

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

Other trials in Argentina

Ukraine8 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49051

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Mykolayiv, 54003

  • GSK Investigational Site

    Vinnytsia, 21018

Other trials in Ukraine

Chile7 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500692

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7860406

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8242238

  • GSK Investigational Site

    Santiago, 7500698

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Talca, Maule Region, 3460001

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

Canada6 sites

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Windsor, Ontario, N8X 5A6

Other trials in Canada

United Kingdom6 sites

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Cambridge, CB2 0QQ

  • GSK Investigational Site

    Oxford, OX3 7LE

  • GSK Investigational Site

    Plymouth, PL6 8DH

  • GSK Investigational Site

    Sheffield, S5 7AU

  • GSK Investigational Site

    Stevenage, SG1 4AB

Other trials in United Kingdom

Slovakia5 sites

  • GSK Investigational Site

    Humenné, 066 01

  • GSK Investigational Site

    Poprad, 058 01

  • GSK Investigational Site

    Šaľa, 927 01

  • GSK Investigational Site

    Spišská Nová Ves, 052 01

  • GSK Investigational Site

    Vráble, 952 01

Other trials in Slovakia

Taiwan5 sites

  • GSK Investigational Site

    Kaohsiung City, 824

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei, 220

  • GSK Investigational Site

    Taipei

  • GSK Investigational Site

    Tau-Yuan County, 333

Other trials in Taiwan

Denmark4 sites

  • GSK Investigational Site

    Aarhus C, 8000

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    København NV, 2400

  • GSK Investigational Site

    Odense C, 5000

Other trials in Denmark

Australia3 sites

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Maroubra, New South Wales, 2035

  • GSK Investigational Site

    Murdoch, Western Australia, 6150

Other trials in Australia

About this study

Official title: Study MEA117113: Mepolizumab vs. Placebo as Add-on Treatment for Frequently Exacerbating COPD Patients Characterized by Eosinophil Level

This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

Being tested
Mepolizumab, Placebo
Keywords
Chronic Obstructive Pulmonary Disease, exacerbations, SB240563, mepolizumab, eosinophils
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.

  • MepolizumabDrug

    Humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with Sterile Water for Injection, just prior to use.

  • PlaceboDrug

    Sterile 0.9percent sodium chloride solution

Study groups in NCT02105961
Study groupRoleWhat they receive
Arm 1ExperimentalEach subject will receive 100 mg mepolizumab SC injection every 4 weeks (13 administrations during 52 week treatment period) along with their baseline standard of care COPD medication
Receives: Drug: Mepolizumab
Arm 2ExperimentalEach subject will receive 300 mg mepolizumab SC injection every 4 weeks (13 administrations during 52 week treatment period) along with their baseline standard of care COPD medication
Receives: Drug: Mepolizumab
Arm 3ExperimentalEach subject will receive placebo (0.9percent sodium chloride) SC injection every 4 weeks (13 administrations during 52 week treatment period) their baseline standard of care COPD medication
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Moderate or Severe Exacerbations

    Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the modified intent-to-treat (mITT) Population (all randomized participants who received at least one dose of study treatment).

    Measured: From randomization to Week 52

Secondary outcomes (4)

  1. Time to First Moderate/Severe Exacerbation

    Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis of time to first moderate/severe exacerbation was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.

    Measured: From randomization to Week 52

  2. Rate of COPD Exacerbations Requiring Emergency Department (ED) Visits and/or Hospitalizations (Hosp)

    COPD exacerbations requiring an ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. This analysis was performed on the mITT population.

    Measured: From randomization to Week 52

  3. Change From Baseline in Mean Total St. George's Respiratory Questionnaire (SGRQ) Score

    The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ , designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores range from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product.Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.

    Measured: Baseline and Week 52

  4. Change From Baseline in Mean COPD Assessment Test (CAT) Score

    The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.

    Measured: Baseline and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2014 (estimated)
  2. Study start24 Apr 2014
  3. Primary completion16 Jan 2017
  4. Study completion16 Jan 2017

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
674 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02105961
Sponsor's protocol ID
117113
Status last verified
Jul 2018
First submitted
3 Apr 2014
Last updated
16 Aug 2018
Data monitoring committee
Yes
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Pavord ID, Chapman KR, Bafadhel M, Sciurba FC, Bradford ES, Schweiker Harris S, Mayer B, Rubin DB, Yancey SW, Paggiaro P. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun 16;16:1755-1770. doi: 10.2147/COPD.S294333. eCollection 2021.

    PubMed 34163157

  • Condreay LD, Gao C, Bradford E, Yancey SW, Ghosh S. No genetic associations with mepolizumab efficacy in COPD with peripheral blood eosinophilia. Respir Med. 2019 Aug;155:26-28. doi: 10.1016/j.rmed.2019.07.004. Epub 2019 Jul 5.

    PubMed 31295674

  • Roger JH, Bratton DJ, Mayer B, Abellan JJ, Keene ON. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment. Pharm Stat. 2019 Jan;18(1):85-95. doi: 10.1002/pst.1910. Epub 2018 Nov 8.

    PubMed 30406948

  • Pavord ID, Chanez P, Criner GJ, Kerstjens HAM, Korn S, Lugogo N, Martinot JB, Sagara H, Albers FC, Bradford ES, Harris SS, Mayer B, Rubin DB, Yancey SW, Sciurba FC. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Oct 26;377(17):1613-1629. doi: 10.1056/NEJMoa1708208. Epub 2017 Sep 11.

    PubMed 28893134

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mepolizumab in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 169 sites in 15 countries.

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 10 inclusion and 33 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, Japan, Germany, South Korea, Netherlands and 10 more countries. 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 6 Apr 2018). 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?

Rate of Moderate or Severe Exacerbations (time frame: From randomization to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02105961, which also lists 4 linked publications.

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 16 Aug 2018.

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