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AzTrials

AsthmaPhase 3NCT01691521

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

A Phase 3 study testing Mepolizumab IV and Mepolizumab SC in people with Asthma, run by GlaxoSmithKline at 134 sites in 16 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 study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. 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 IV and Mepolizumab SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
580 participants
Where
134 sitesin 16 countries
Study dates
8 Oct 2012to 18 Jan 2014
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

  • Able to give written informed consent prior to participation in the study
  • At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg)
  • 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)
  • 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
  • Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma
  • At Visit 1, a pre-bronchodilator FEV1 <80% (for subjects >= 18 years of age), a pre-bronchodilator FEV1 <90% or FEV1:FVC ratio <0.8 (for subjects 12-17 years of age).
Show all 9Show fewer
  • Previously confirmed history of two or more exacerbations requiring treatment with systemic CS
  • Male or Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
  • French subjects will be included only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Current smokers or former smokers with a smoking history of >=10 pack years
  • Presence of a known pre-existing, clinically important lung condition other than asthma
  • A current malignancy or previous history of malignancy in less than 12 months
  • Known, pre-existing, unstable liver disease cirrhosis and known biliary abnormalities
  • Known, pre-existing severe or clinically significant cardiovascular disease
  • known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment
Show all 16Show fewer
  • Subjects with any eosinophilic diseases
  • QTc(F) ≥450msec or QTc(F) ≥480 msec
  • A history of alcohol/substance abuse
  • Subject with known immunodeficiency
  • Subjects who have received omalizumab within 130 days of Visit 1 or any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1
  • Subjects 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
  • Subjects with allergy/intolerance to a monoclonal antibody or biologic.
  • Subjects who are pregnant or breastfeeding
  • Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations
  • Previously participated in any study with mepolizumab and received investigational product (including placebo)

Trial locations and contacts

134 sites in 16 countries.

134 sites in 16 countries

Japan22 sites

  • GSK Investigational Site

    Chiba, 296-8602

  • GSK Investigational Site

    Fukuoka, 802-0052

  • GSK Investigational Site

    Fukuoka, 811-1394

  • GSK Investigational Site

    Fukuoka, 832-0059

  • GSK Investigational Site

    Gunma, 370-0615

  • GSK Investigational Site

    Hiroshima, 732-0052

  • GSK Investigational Site

    Hokkaido, 062-8618

  • GSK Investigational Site

    Hokkaido, 070-8644

  • GSK Investigational Site

    Hyōgo, 651-0072

  • GSK Investigational Site

    Hyōgo, 672-8064

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Kanagawa, 252-0392

  • GSK Investigational Site

    Kumamoto, 861-1196

  • GSK Investigational Site

    Mie, 515-8544

  • GSK Investigational Site

    Okinawa, 901-2132

  • GSK Investigational Site

    Okinawa, 904-2293

  • GSK Investigational Site

    Osaka, 560-8552

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Tokyo, 102-0083

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 171-0014

  • GSK Investigational Site

    Tokyo, 187-0024

Other trials in Japan

United States21 sites

  • GSK Investigational Site

    Albany, Georgia, 31707

  • GSK Investigational Site

    Baltimore, Maryland, 21224

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Cincinnati, Ohio, 45229

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Columbus, Ohio, 43221

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Durham, North Carolina, 27705

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Haven, Connecticut, 06520

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    Newport Beach, California, 92663

  • 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, 84132-2409

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada13 sites

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Edmonton, Alberta, T6G2E1

  • GSK Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • GSK Investigational Site

    Montreal, Quebec, H2W 1T8

  • GSK Investigational Site

    Montreal, Quebec, H2X 2P4

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • 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

Germany11 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Potsdam, Brandenburg, 14478

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

Other trials in Germany

South Korea11 sites

  • GSK Investigational Site

    Anyang-si, 431-070

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Cheongju, Chungcheongbuk-do, 361-711

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Donggu Gwangju, 501757

  • GSK Investigational Site

    Incheon, 405-760

  • GSK Investigational Site

    Jeonju-si, Jeollabuk-Do, 561-712

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Italy8 sites

  • GSK Investigational Site

    Cittadella PD, Veneto, 35013

  • GSK Investigational Site

    Foggia, Apulia, 71100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43125

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Pietra Ligure (SV), Liguria, 17027

  • GSK Investigational Site

    Pisa, Tuscany, 56124

Other trials in Italy

Argentina7 sites

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FZN

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000DBS

  • GSK Investigational Site

    San Rafael, Mendoza Province, 5600

Other trials in Argentina

France7 sites

  • GSK Investigational Site

    Le Kremlin-Bicêtre, 94275

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Lyon, 69317

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Perpignan, 66000

  • GSK Investigational Site

    Saint-Pierre, 97448

Other trials in France

Australia5 sites

  • GSK Investigational Site

    Bedford Park, South Australia, 5042

  • GSK Investigational Site

    Clayton, Victoria, 3168

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    New Lambton, New South Wales, 2305

  • GSK Investigational Site

    Parkville, 3052

Other trials in Australia

Spain5 sites

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08041

  • GSK Investigational Site

    Barcelona, 08208

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

Other trials in Spain

United Kingdom5 sites

  • GSK Investigational Site

    Bradford, BD9 6RJ

  • GSK Investigational Site

    Glasgow, G11 6NT

  • GSK Investigational Site

    London, EC1M 6BQ

  • GSK Investigational Site

    Plymouth, PL6 8DH

  • GSK Investigational Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Belgium4 sites

  • GSK Investigational Site

    Brussels, 1020

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Mexico4 sites

  • GSK Investigational Site

    México DF, 14050

  • GSK Investigational Site

    Monterrey, Nuevo León, 64020

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

  • GSK Investigational Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Russia4 sites

  • GSK Investigational Site

    Chelyabinsk, 454106

  • GSK Investigational Site

    Moscow, 123182

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 194356

Other trials in Russia

Ukraine4 sites

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Mykolayiv, 54003

  • GSK Investigational Site

    Vinnytsia, 21018

Other trials in Ukraine

Chile3 sites

  • GSK Investigational Site

    Rancagua, Reg Del Libert Bern Ohiggins, 2841959

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Talcahuano, 4270918

Other trials in Chile

About this study

Official title: MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events.

This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC.

Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

Conditions
Asthma
Being tested
Mepolizumab IV, Mepolizumab SC, IV Placebo, SC Placebo
Keywords
safety, SB-240563, efficacy, placebo, eosinophils, mepolizumab, Severe refractory asthma
Medical subject headings
Asthma

What participants receive

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

  • Mepolizumab IVDrug

    Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28

  • Mepolizumab SCDrug

    Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28

  • IV PlaceboDrug

    Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28

  • SC PlaceboDrug

    Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28

Study groups in NCT01691521
Study groupRoleWhat they receive
Mepolizumab IVExperimentalMepolizumab 75 mg will be administered intravenously approximately every 4 weeks with the last dose at week 32. Subjects in the Mepolizumab IV arm will receive mepolizumab 75 mg intravenously and placebo SC once every 4 weeks with the last dose at Week 28 (total of 8 doses)
Receives: Drug: Mepolizumab IV; Drug: SC Placebo
Mepolizumab SCExperimentalSubjects in the Mepolizumab SC arm will receive mepolizumab 100 mg SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)
Receives: Drug: Mepolizumab SC; Drug: IV Placebo
PlaceboPlacebo comparatorSubjects in the Placebo arm will receive matching placebo SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)
Receives: Drug: IV Placebo; Drug: SC Placebo

What is being measured

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

  1. Number of Clinically Significant Exacerbations of Asthma Per Year

    Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.

    Measured: From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose

Secondary outcomes (4)

  1. Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year

    Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.

    Measured: From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose

  2. Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year

    Clinically significant exacerbations of asthma is defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.

    Measured: From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose

  3. Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32

    FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using mixed model repeated measures with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by baseline and visit by treatment group.

    Measured: Baseline, Week 32

  4. Mean Change From Baseline in the St. George's Respiratory Questionnaire Total Score at Week 32

    The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. The lowest possible value is zero and the highest possible value is 100. The higher values correspond to greater impairment in quality of life. The questionnaire was administered at Baseline (Visit 2) and at the Exit Visit (approximately 4 weeks after the last dose of study treatment). The change from baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using analysis of covariance with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, and treatment.

    Measured: Baseline, Week 32

Timeline

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

  1. First posted24 Sep 2012 (estimated)
  2. Study start8 Oct 2012
  3. Primary completion1 Jan 2014
  4. Study completion18 Jan 2014

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
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01691521
Sponsor's protocol ID
115588
Status last verified
Aug 2018
First submitted
20 Sep 2012
Last updated
6 Aug 2018
Data monitoring committee
Yes
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

  • Chen W, Reddel HK, FitzGerald JM, Beasley R, Janson C, Sadatsafavi M. Can we predict who will benefit most from biologics in severe asthma? A post-hoc analysis of two phase 3 trials. Respir Res. 2023 May 2;24(1):120. doi: 10.1186/s12931-023-02409-2.

    PubMed 37131185

  • 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

  • Best N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing. Pharm Stat. 2021 May;20(3):551-562. doi: 10.1002/pst.2093. Epub 2021 Jan 21.

    PubMed 33475231

  • Wardlaw A, Howarth PH, Israel E, Taille C, Quirce S, Mallett S, Bates S, Albers FC, Kwon N. Fungal sensitization and its relationship to mepolizumab response in patients with severe eosinophilic asthma. Clin Exp Allergy. 2020 Jul;50(7):869-872. doi: 10.1111/cea.13680. Epub 2020 Jun 25. No abstract available.

    PubMed 32515118

  • Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

    PubMed 32450626

  • Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

    PubMed 31447130

  • Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239. doi: 10.2500/aap.2019.40.4229.

    PubMed 31262378

  • 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 HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.

    PubMed 30954640

  • 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

  • Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

    PubMed 29398640

  • Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

    PubMed 29258789

  • Albers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. J Allergy Clin Immunol. 2017 Nov;140(5):1464-1466.e4. doi: 10.1016/j.jaci.2017.06.010. Epub 2017 Jul 4. No abstract available.

    PubMed 28687231

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mepolizumab IV and Mepolizumab SC in people with Asthma, run by GlaxoSmithKline at 134 sites in 16 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 16 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 134 sites in Japan, United States, Canada, Germany, South Korea and 11 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 26 Jan 2016). 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?

Number of Clinically Significant Exacerbations of Asthma Per Year (time frame: From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose). 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 NCT01691521, which also lists 17 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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