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AsthmaPhase 3NCT02281318

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control

A Phase 3 study testing Mepolizumab and SOC in people with Asthma, run by GlaxoSmithKline at 144 sites in 19 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-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Mepolizumab and SOC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
556 participants
Where
144 sitesin 19 countries
Study dates
11 Dec 2014to 10 Jun 2016
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age: At least 12 years of age at the time of signing the informed consent/assent (For those countries where local regulations permit enrolment of adults only, participant recruitment will be restricted to those who are >=18 years of age)
  • Inhaled Corticosteroid: A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS). For participants >=18 years old: ICS dose must be >=880 micrograms (mcg)/day fluticasone propionate (FP) (exactuator) or equivalent daily. For ICS/long-acting beta-2-agonist (LABA) combination preparations, the highest approved maintenance dose in the local country will meet this ICS criterion. For participants >=12 to <=17 years old: ICS dose must be >=440 mcg/day FP (ex-actuator) or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion
  • Controller Medication: Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months (e.g. LABA, leukotriene receptor antagonist [LTRA], or theophylline)
  • Eosinophilic asthma: Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomisation Criteria 1 and 2
  • FEV1: Persistent airflow obstruction as indicated by : For participants >=18 years of age at visit 1, a pre-bronchodilator FEV1 <80% predicted (National Health and Nutrition Examination Survey [NHANES III]) recorded at Visit 1. For participants 12-17 years of age at Visit 1: A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded at Visit 1 OR FEV1:FVC ratio <0.8 recorded at Visit 1
  • Exacerbation history: Previously confirmed history of two or more exacerbations requiring treatment with systemic Corticosteroid (CS) (intramuscular, intravenous, or oral), in the 12 months prior to visit 1, despite the use of high-dose inhaled corticosteroids (ICS). For participants receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.
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  • Gender: Male or Eligible Female. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control listed in the protocol for the duration of the trial and for 4 months after the last study drug administration.
  • Informed Consent/Assent: Able to give written informed consent/assent prior to participation in the core study, which will include the ability to comply with the requirements and restrictions listed in the consent/assent form and in this protocol. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. Written informed consent must be obtained from ALL patients/legally authorized representative(s); for patients 12-17 years old, written informed assent must be obtained in addition to the legally authorized representative(s)' consent.
  • French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Smoking history: Current smokers or former smokers with a smoking history of >=10 pack years (number of pack years = (number of cigarettes per day/20) x number of years smoked). A former smoker is defined as a participant who quit smoking at least 6 months prior to Visit 1.
  • Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
  • Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
  • Liver Disease: Known, pre-existing, 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).
  • Cardiovascular: Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to: (a) known ejection fraction of <30% OR (b) severe heart failure meeting New York Heart Association Class IV classification OR (c) hospitalised in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III OR (d) angina diagnosed less than 3 months prior to Visit 1 or at Visit 1.
  • Other Concurrent Medical Conditions: Participants who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
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  • Eosinophilic Diseases: Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis [EGPA]), or Eosinophilic Esophagitis. Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 are also to be excluded.
  • Electrocardiogram (ECG) Assessment: QT interval corrected for heart rate by Fridericia's formula (QTc(F)) >=450 milliseconds (msec) or QTc(F) >=480 msec for participants with Bundle Branch Block at Visit 1.
  • Alcohol/Substance Abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
  • Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus [HIV]), other than that explained by the use of corticosteroids taken as therapy for asthma.
  • Xolair: Participants who have received omalizumab (Xolair) within 130 days of Visit 1.
  • Other Monoclonal Antibodies: Participants who have received any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
  • Investigational Medications: Participants who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products).
  • Hypersensitivity: Participants with allergy/intolerance to a monoclonal antibody or biologic.
  • Pregnancy: Participants who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test is required of all women of child bearing potential. This test will be performed at the time points specified in the Time and Events Schedule in protocol.
  • Adherence: Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
  • Previous participation: Previously participated in any study with mepolizumab and received investigational product (including placebo)

Trial locations and contacts

144 sites in 19 countries.

144 sites in 19 countries

United States24 sites

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Baltimore, Maryland, 21236

  • GSK Investigational Site

    Birmingham, Alabama, 35243

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Durham, North Carolina, 27705

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    New Haven, Connecticut, 06520

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Orlando, Florida, 32825

  • GSK Investigational Site

    Rapid City, South Dakota, 57702

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    Rochester, New York, 14642

  • GSK Investigational Site

    Rolling Hills Estates, California, 90274

  • GSK Investigational Site

    Salt Lake City, Utah, 84132

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Upland, Pennsylvania, 19013

  • GSK Investigational Site

    Williamsburg, Virginia, 23188

Other trials in United States

Germany12 sites

  • GSK Investigational Site

    Bamberg, Bavaria, 96049

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Hamburg, 20354

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Munich, Bavaria, 80539

  • GSK Investigational Site

    Schleswig, Schleswig-Holstein, 24837

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58452

Other trials in Germany

Canada10 sites

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    St-Charles-Borromée, Ontario, J6E 2B4

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • GSK Investigational Site

    Windsor, Ontario, N8X 5A6

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

France10 sites

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Lyon, 69317

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Pessac, 33604

  • GSK Investigational Site

    Reims, 51092

Other trials in France

Ukraine10 sites

  • GSK Investigational Site

    Dnipro, 49074

  • GSK Investigational Site

    Kharkiv, 61093

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Odesa, 65025

  • GSK Investigational Site

    Vinnytsia, 21018

  • GSK Investigational Site

    Vinnytsia, 21029

  • GSK Investigational Site

    Zaporizhia, 69076

Other trials in Ukraine

Russia9 sites

  • GSK Investigational Site

    Irkutsk, 664043

  • GSK Investigational Site

    Moscow, 115211

  • GSK Investigational Site

    Novosibirsk, 630102

  • GSK Investigational Site

    Saint Petersburg, 198216

  • GSK Investigational Site

    Saint Petesburg, 195030

  • GSK Investigational Site

    Sestroretsk, 197706

  • GSK Investigational Site

    Stavropol, 355030

  • GSK Investigational Site

    Voronezh, 394066

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Argentina8 sites

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Concepción del Uruguay, Entre Ríos Province, 3260

  • 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

    Rosario, Santa Fe Province, 2000

  • GSK Investigational Site

    San Rafael, Mendoza Province, 5600

Other trials in Argentina

Spain8 sites

  • GSK Investigational Site

    Alcorcón (Madrid), 28922

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Barcelona, 08041

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

Czechia7 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Hlučín, 748 01

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Olomouc, 775 20

  • GSK Investigational Site

    Pilsen, 305 99

  • GSK Investigational Site

    Prague, 140 59

Other trials in Czechia

Greece7 sites

  • GSK Investigational Site

    Athens, 106 76

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Haidari / Athens, 124 62

  • GSK Investigational Site

    Rethymnon, Crete, 74100

  • GSK Investigational Site

    Thessaloniki, 56403

  • GSK Investigational Site

    Thessaloniki, 56429

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Italy7 sites

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Chieti, Abruzzo, 66100

  • GSK Investigational Site

    Florence, Tuscany, 50134

  • GSK Investigational Site

    Foggia, Apulia, 71100

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Reggio Emilia, Emilia-Romagna, 42100

Other trials in Italy

Belgium5 sites

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Erpent, 5101

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Netherlands5 sites

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Leiden, 2333 ZA

  • GSK Investigational Site

    Rotterdam, 3045 PM

Other trials in Netherlands

Peru5 sites

  • GSK Investigational Site

    Lima, Lima Province, Lima 27

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    Lima, Lima 32

  • GSK Investigational Site

    San Martín de Porres, Lima region, Lima 31

  • GSK Investigational Site

    San Miguel, Lima region, Lima 32

Other trials in Peru

Norway4 sites

  • GSK Investigational Site

    Bergen, 5021

  • GSK Investigational Site

    Oslo, 0405

  • GSK Investigational Site

    Stavanger, 4011

  • GSK Investigational Site

    Trondheim, 7006

Other trials in Norway

Slovakia4 sites

  • GSK Investigational Site

    Bojnice, 972 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

United Kingdom4 sites

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Oxford, OX3 7LE

  • GSK Investigational Site

    Plymouth, PL6 8DH

  • GSK Investigational Site

    Swansea, SA2 8PP

Other trials in United Kingdom

Estonia3 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Bulgaria2 sites

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Sofia, 1431

Other trials in Bulgaria

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Eosinophilic Asthma on Markers of Asthma Control

This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function.

Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

Conditions
Asthma
Being tested
Mepolizumab, Placebo, SOC
Keywords
Asthma control, Lung function, Health-related quality of life, Mepolizumab, Severe Eosinophilic asthma
Medical subject headings
Asthma, Pulmonary Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MepolizumabBiological

    Humanised Immunoglobulin G (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 0.9% sodium chloride solution

  • SOCDrug

    Standard of Care (SOC) will differ by participants, however it will include high dose ICS with at least one other controller, e.g. LABA, with or without maintenance OCS

Study groups in NCT02281318
Study groupRoleWhat they receive
Mepolizumab SCExperimentalParticipants will receive Mepolizumab 100 mg subcutaneously (SC) into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses) along with their respective standard care of treatment
Receives: Biological: Mepolizumab; Drug: SOC
Placebo SCPlacebo comparatorParticipants will receive placebo (0.9% sodium chloride) subcutaneously into the upper arm or thigh every 4 weeks for a period of 24 weeks (total of 6 doses) along with their respective standard care of treatment
Receives: Drug: Placebo; Drug: SOC

What is being measured

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

  1. Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24

    SGRQ consisted of 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure Quality of Life in par. with diseases of airway obstruction, measuring symptoms, impact, and activity. Questions were completed by the par. with a recall over the past 4 weeks. SGRQ Total Score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100 to get a %. Change from BL in SGRQ was calculated as value at Week 24 minus value at BL for each par. and was analyzed using mixed model repeated measures allowing for covariates of BL value, region, BL maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1 and visit, plus interaction terms for visit by BL and visit by treatment group. Modified Intent-to-Treat (mITT) Population consisted of all randomized par. who received >= 1 dose of drug.

    Measured: Baseline and Week 24

Secondary outcomes (3)

  1. Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 24

    FEV1 is the volume of air that can be forced out in one second after taking a deep breath. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline for each subject and was analyzed using a mixed model repeated measures adjusting for Baseline absolute pre-bronchodilator FEV1, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study and visit, plus interaction terms for visit by Baseline and visit by treatment group.

    Measured: Baseline and Week 24

  2. Percentage of Participants Achieving a 4 Point or Greater Reduction From Baseline in SGRQ Score at Week 24

    The percentage of participants achieving a 4 point or greater reduction from Baseline in SGRQ (scored from 0-100 with lower scores indicating better outcome) at Week 24 was compared between treatment groups using a logistic regression model with covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and Baseline % predicted FEV1.

    Measured: Baseline (Visit 2-latest pre-dose assessment) and Week 24

  3. Mean Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24

    The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. ACQ-5 score is the mean score of 5 questions, each assessed on a 0-6 point scale to give a mean ranging between 0-6 with lower scores indicating better outcome. The five questions inquired about the frequency and/or severity of symptoms over the previous week. The response options for all these questions consisted of a zero (no impairment/limitation) to six (total impairment/limitation) scale. The mean change from Baseline was calculated as the value at Week 24 minus the Baseline value for each participant and analyzed using a mixed model repeated measures allowing for covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable), Baseline % predicted FEV1 and visit, plus interaction terms for visit by Baseline and visit by treatment group.

    Measured: Baseline and Week 24

Timeline

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

  1. First posted3 Nov 2014 (estimated)
  2. Study start11 Dec 2014
  3. Primary completion10 Jun 2016
  4. Study completion10 Jun 2016

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
Double blind
Who is masked
Participant, Investigator
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02281318
Sponsor's protocol ID
200862
Status last verified
Aug 2018
First submitted
30 Oct 2014
Last updated
6 Aug 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Lemiere C, Taille C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.

    PubMed 34158028

  • Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

    PubMed 34098955

  • Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

    PubMed 31507641

  • Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

    PubMed 31251094

  • Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of >/=150-300 cells/muL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

    PubMed 31047111

  • Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

    PubMed 29949045

  • Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, Ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 May;5(5):390-400. doi: 10.1016/S2213-2600(17)30125-X. Epub 2017 Apr 5.

    PubMed 28395936

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mepolizumab and SOC in people with Asthma, run by GlaxoSmithKline at 144 sites in 19 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 9 inclusion and 17 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 6 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 144 sites in United States, Germany, Canada, France, Ukraine and 14 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. Some participants in this study may receive a placebo. 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 4 May 2017). 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?

Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24 (time frame: Baseline and Week 24). 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 NCT02281318, which also lists 7 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 6 Aug 2018.

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