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

NCT ID: NCT02105961

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 674 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-24
• Study Completion Date: 2017-01-16

Brief 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. 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Each 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

Group Type: EXPERIMENTAL

Mepolizumab

Intervention Type: DRUG

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.

Arm 2

Each 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

Group Type: EXPERIMENTAL

Mepolizumab

Intervention Type: DRUG

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.

Arm 3

Each 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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Sterile 0.9percent sodium chloride solution

Interventions

Mepolizumab

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.

Intervention Type: DRUG

Placebo

Sterile 0.9percent sodium chloride solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

• 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.
• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Riverside, California, United States

GSK Investigational Site

Upland, California, United States

GSK Investigational Site

Broomfield, Colorado, United States

GSK Investigational Site

Stamford, Connecticut, United States

GSK Investigational Site

Boynton Beach, Florida, United States

GSK Investigational Site

DeLand, Florida, United States

GSK Investigational Site

Edgewater, Florida, United States

GSK Investigational Site

Gainesville, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

Adairsville, Georgia, United States

GSK Investigational Site

Duluth, Georgia, United States

GSK Investigational Site

Woodstock, Georgia, United States

GSK Investigational Site

Coeur d'Alene, Idaho, United States

GSK Investigational Site

Bowling Green, Kentucky, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Gastonia, North Carolina, United States

GSK Investigational Site

Huntersville, North Carolina, United States

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Columbus, Ohio, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Hershey, Pennsylvania, United States

GSK Investigational Site

Oaks, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Easley, South Carolina, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

GSK Investigational Site

Rock Hill, South Carolina, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Morgantown, West Virginia, United States

GSK Investigational Site

Bahía Blanca, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Plata, Buenos Aires, Argentina

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

Berazategui, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Mendoza, , Argentina

GSK Investigational Site

Mendoza, , Argentina

GSK Investigational Site

Coffs Harbour, New South Wales, Australia

GSK Investigational Site

Maroubra, New South Wales, Australia

GSK Investigational Site

Murdoch, Western Australia, Australia

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Burlington, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Windsor, Ontario, Canada

GSK Investigational Site

Saint-Charles-Borromée, Quebec, Canada

GSK Investigational Site

Trois-Rivières, Quebec, Canada

GSK Investigational Site

Talca, Maule Region, Chile

GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Aarhus C, , Denmark

GSK Investigational Site

Hvidovre, , Denmark

GSK Investigational Site

København NV, , Denmark

GSK Investigational Site

Odense C, , Denmark

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Rüdersdorf, Brandenburg, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

GSK Investigational Site

Neu-Isenburg, Hesse, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Ehime, , Japan

GSK Investigational Site

Fukui, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukushima, , Japan

GSK Investigational Site

Gifu, , Japan

GSK Investigational Site

Hiroshima, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Kagawa, , Japan

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Kanagawa, , Japan

GSK Investigational Site

Kumamoto, , Japan

GSK Investigational Site

Mie, , Japan

GSK Investigational Site

Miyagi, , Japan

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Miyagi, , Japan

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Miyagi, , Japan

GSK Investigational Site

Okayama, , Japan

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Okayama, , Japan

GSK Investigational Site

Okinawa, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Ōita, , Japan

GSK Investigational Site

Shimane, , Japan

GSK Investigational Site

Shizuoka, , Japan

GSK Investigational Site

Shizuoka, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

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Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

GSK Investigational Site

's-Hertogenbosch, , Netherlands

GSK Investigational Site

Almelo, , Netherlands

GSK Investigational Site

Breda, , Netherlands

GSK Investigational Site

Groningen, , Netherlands

GSK Investigational Site

Hoofddorp, , Netherlands

GSK Investigational Site

Horn, , Netherlands

GSK Investigational Site

Leiden, , Netherlands

GSK Investigational Site

Sittard-geleen, , Netherlands

GSK Investigational Site

Utrecht, , Netherlands

GSK Investigational Site

Zutphen, , Netherlands

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

GSK Investigational Site

Codlea, , Romania

GSK Investigational Site

Craiova, , Romania

GSK Investigational Site

Focşani, , Romania

GSK Investigational Site

Iași, , Romania

GSK Investigational Site

Piteşti, , Romania

GSK Investigational Site

Ploieşti, , Romania

GSK Investigational Site

Timișoara, , Romania

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Humenné, , Slovakia

GSK Investigational Site

Poprad, , Slovakia

GSK Investigational Site

Spišská Nová Ves, , Slovakia

GSK Investigational Site

Šaľa, , Slovakia

GSK Investigational Site

Vráble, , Slovakia

GSK Investigational Site

Anyang-Si Gyeonggi-do, , South Korea

GSK Investigational Site

Bucheon City, Gyenggi-do, , South Korea

GSK Investigational Site

Busan, , South Korea

GSK Investigational Site

Cheongju, Chungcheongbuk-do, , South Korea

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Jeonju, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Wonju-si, Kanwon-do, , South Korea

GSK Investigational Site

Kaohsiung City, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Tau-Yuan County, , Taiwan

GSK Investigational Site

Dnipropetrovsk, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kiev, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Mykolayiv, , Ukraine

GSK Investigational Site

Vinnytsia, , Ukraine

GSK Investigational Site

Bradford, , United Kingdom

GSK Investigational Site

Cambridge, , United Kingdom

GSK Investigational Site

Oxford, , United Kingdom

GSK Investigational Site

Plymouth, , United Kingdom

GSK Investigational Site

Sheffield, , United Kingdom

GSK Investigational Site

Stevenage, , United Kingdom

Countries

United States; Argentina; Australia; Canada; Chile; Denmark; Germany; Japan; Netherlands; Romania; Slovakia; South Korea; Taiwan; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34163157 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31295674 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30406948 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28893134 (View on PubMed)

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

117113

Identifier Type: -

Identifier Source: org_study_id