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AsthmaPhase 2DREAMNCT01000506

Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma

A Phase 2 study testing Mepolizumab 750, Mepolizumab 250 and Mepolizumab 75 in people with Asthma, run by GlaxoSmithKline at 94 sites in 13 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

The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Asthma
What is being tested?
Mepolizumab 750, Mepolizumab 250 and Mepolizumab 75
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
621 participants
Where
94 sitesin 13 countries
Study dates
1 Nov 2009to 23 Mar 2012
Phase
Phase 2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female
  • Aged 12 to 65 years inclusive
  • Minimum weight 45kg
  • Clinical features of severe refractory asthma
  • Well documented requirement for high dose inhaled corticosteroids (ICS) [i.e. >= 880mcg/day fluticasone propionate or equivalent daily] for at least 12 months
  • Using additional controller medication in addition to high dose ICS for at least 12 months
Show all 15Show fewer
  • Persistent airflow obstruction indicated by a pre-bronchodilator FEV1<80% predicted at visit 1 or 2 or peak flow diurnal variability of >20% on 3 or more days during the run-in
  • Airway inflammation which is likely to be eosinophilic in nature demonstrated by either raised peripheral blood eosinophils (>=300/microL), sputum eosinophils (>=3%), exhaled nitric oxide (>=50ppb) or prompt deterioration of asthma control following a <=25% reduction in regular maintenance dose of inhaled or oral corticosteroids (OCS)
  • History of 2 or more exacerbations requiring systemic corticosteroids in the previous 12 months
  • Evidence of asthma documented by airway reversibility, airway hyperresponsiveness or airflow variability
  • ECG assessment demonstrating QTc<450msec or QTc<480msec for patients with bundle branch block
  • Liver function tests demonstrating ALT<2xUpper Limit of Normal (ULN), AST<2xULN, Alk Phos <=1.5xULN, bilirubin <=1.5xULN
  • Female of non-child-bearing potential or child-bearing potential with a negative pregnancy test at screening and prepared to agree to an acceptable method of contraception
  • Able to give written informed consent
  • Able to read, comprehend and write at a sufficient level to complete study materials

Who cannot join

  • Current smokers or smoking history of >=10 pack years
  • Clinically important lung condition other than asthma
  • Diagnosis of malignancy or in the process of investigation
  • Unstable liver disease
  • Churg-Strauss syndrome
  • Using methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine or any experimental anti-inflammatory therapy within 3 months of screening
Show all 18Show fewer
  • Omalizumab (Xolair) or any other biological for the treatment of inflammatory disease within 6 months of Visit 1
  • Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months
  • Allergy/intolerance to the excipients in the mepolizumab formulation
  • Any investigational drug within 30 days or 5 terminal half-lives, whichever is longer
  • Pregnant or breastfeeding or planning to become pregnant
  • Clinically significant disease which is uncontrolled with standard treatment
  • History of alcohol misuse or substance abuse
  • Parasitic infestation within previous 6 months
  • Known immunodeficiency
  • Unable to follow instructions, use the electronic diary or peak flow meter
  • Known evidence of lack of adherence to controller medications and/or follow physician's recommendations
  • Previous participation in a study of mepolizumab and received study medication within 90 days

Trial locations and contacts

94 sites in 13 countries.

94 sites in 13 countries

United States21 sites

  • GSK Investigational Site

    Albany, Georgia, 31707

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Cleveland, Ohio, 44195

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Denver, Colorado, 80206

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Houston, Texas, 77054

  • GSK Investigational Site

    Lexington, Kentucky, 40508

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, PA 15213

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    San Diego, California, 92103-8415

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Ukraine11 sites

  • GSK Investigational Site

    Cherkassy, 18009

  • GSK Investigational Site

    Dnipropetrovsk, 49006

  • GSK Investigational Site

    Dnipropetrovsk, 49027

  • GSK Investigational Site

    Dnipropetrovsk, 49051

  • GSK Investigational Site

    Donetsk, 83003

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03115

  • GSK Investigational Site

    Mykolayiv, 54003

Other trials in Ukraine

Germany9 sites

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 14050

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

Other trials in Germany

Russia9 sites

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Chelyabinsk, 454106

  • GSK Investigational Site

    Kazan', 420015

  • GSK Investigational Site

    Moscow, 105 077

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Moscow, 123 182

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 198216

  • GSK Investigational Site

    Tomsk, 634001

Other trials in Russia

Poland6 sites

  • GSK Investigational Site

    Bialystok, 15-276

  • GSK Investigational Site

    Lodz, 90-153

  • GSK Investigational Site

    Warsaw, 01-138

  • GSK Investigational Site

    Wroclaw, 54-239

  • GSK Investigational Site

    Zawadzkie, 47-120

  • GSK Investigational Site

    Zgierz, 95-100

Other trials in Poland

Argentina5 sites

  • GSK Investigational Site

    Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FZN

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Australia5 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Clayton, Victoria, 3168

  • GSK Investigational Site

    Melbourne, Victoria, 3004

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    New Lambton, New South Wales, 2305

Other trials in Australia

Canada5 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Mississauga, Ontario, L5A 3V4

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

France5 sites

  • GSK Investigational Site

    Clamart, 92140

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Saint-Pierre, 97448

Other trials in France

South Korea5 sites

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Cheongju, Chungcheongbuk-do, 361-711

  • GSK Investigational Site

    Seoul, 133--792

  • GSK Investigational Site

    Seoul, 152-703

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

United Kingdom5 sites

  • GSK Investigational Site

    Leicester, Leicestershire, LE3 9QP

  • GSK Investigational Site

    London, E1 2AT

  • GSK Investigational Site

    London, SW3 6HP

  • GSK Investigational Site

    Manchester, M23 9LT

  • GSK Investigational Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Chile4 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Talcahuano, 4270918

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

Romania4 sites

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Bucharest, 70000

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Târgu Mureş, 540143

Other trials in Romania

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

Read the detailed description

A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.

Conditions
Asthma
Being tested
Mepolizumab 750, Mepolizumab 250, Mepolizumab 75, Placebo saline
Keywords
Dose-ranging, Safety, Pharmacodynamics, eosinophils, SB-240563, Efficacy, Severe refractory asthma, mepolizumab, Placebo
Medical subject headings
Asthma

What participants receive

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

  • Mepolizumab 750Biological

    Mepolizumab 750mg every four weeks by i.v.

  • Mepolizumab 250Biological

    Mepolizumab 250mg every four weeks by i.v.

  • Mepolizumab 75Biological

    Mepolizumab 75mg every four weeks by i.v.

  • Placebo salineDrug

    Placebo saline every four weeks by i.v.

Study groups in NCT01000506
Study groupRoleWhat they receive
Mepolizumab 750mgActive comparatorMepolizumab 750mcg i.v. every 4 weeks
Receives: Biological: Mepolizumab 750
Mepolizumab 250mgActive comparatorMepolizumab 250mcg i.v. every 4 weeks
Receives: Biological: Mepolizumab 250
Mepolizumab 75mgActive comparatorMepolizumab 75mcg i.v. every 4 weeks
Receives: Biological: Mepolizumab 75
PlaceboPlacebo comparatorPlacebo saline every 4 weeks i.v.
Receives: Drug: Placebo saline

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 oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable

    Measured: From randomization (Week 0) to Week 52 or early withdrawal (EW)

Secondary outcomes (8)

  1. Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit

    Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).

    Measured: From randomization (Week 0) to Week 52 or EW

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

    The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.

    Measured: From randomization (Week 0) to Week 52 or EW

  3. Time to First Exacerbation Requiring Hospitalization or ED Visit

    Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).

    Measured: From randomization (Week 0) to Week 52 or EW

  4. Number of All Recorded Exacerbations Per Year

    Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.

    Measured: From randomization (Week 0) to Week 52 or EW

  5. Time to First All Recorded Exacerbation

    All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).

    Measured: From randomization (Week 0) to Week 52 or EW

  6. Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period

    FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. 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 was 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: From Baseline up to Week 52 or EW

  7. Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period

    FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. 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 was 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

    Measured: From Baseline up to Week 52 or EW

  8. Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period

    The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.

    Measured: From Baseline up to Week 52 or EW

Timeline

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

  1. First posted23 Oct 2009 (estimated)
  2. Study start1 Nov 2009
  3. Primary completion23 Mar 2012
  4. Study completion23 Mar 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
621 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01000506
Sponsor's protocol ID
112997
Acronym
DREAM
Status last verified
Jan 2018
First submitted
22 Oct 2009
Last updated
24 Jan 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

  • Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.

    PubMed 22901886

  • 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

  • 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

  • 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

  • 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, 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

  • Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab. A step closer to personalized medicine for patients with severe asthma. Ann Am Thorac Soc. 2014 Sep;11(7):1011-7. doi: 10.1513/AnnalsATS.201312-454OC.

    PubMed 24983709

  • Prazma CM, Wenzel S, Barnes N, Douglass JA, Hartley BF, Ortega H. Characterisation of an OCS-dependent severe asthma population treated with mepolizumab. Thorax. 2014 Dec;69(12):1141-2. doi: 10.1136/thoraxjnl-2014-205581. Epub 2014 May 16.

    PubMed 24834924

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mepolizumab 750, Mepolizumab 250 and Mepolizumab 75 in people with Asthma, run by GlaxoSmithKline at 94 sites in 13 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 15 inclusion and 18 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Ukraine, Germany, Russia, Poland and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Feb 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 52 or early withdrawal (EW)). 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 NCT01000506, which also lists 9 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 24 Jan 2018.

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