Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)
18 januari 2018 uppdaterad av: GlaxoSmithKline
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
621
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Buenos Aires, Argentina, 1425
- GSK Investigational Site
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Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
- GSK Investigational Site
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Mendoza, Argentina, M5500CCG
- GSK Investigational Site
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Tucuman, Argentina, 4000
- GSK Investigational Site
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, B7600FZN
- GSK Investigational Site
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New South Wales
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New Lambton, New South Wales, Australien, 2305
- GSK Investigational Site
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South Australia
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Adelaide, South Australia, Australien, 5000
- GSK Investigational Site
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Victoria
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Clayton, Victoria, Australien, 3168
- GSK Investigational Site
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Melbourne, Victoria, Australien, 3004
- GSK Investigational Site
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Western Australia
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Nedlands, Western Australia, Australien, 6009
- GSK Investigational Site
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Santiago, Chile, 8380453
- GSK Investigational Site
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Talcahuano, Chile, 4270918
- GSK Investigational Site
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Región Metro De Santiago
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Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
- GSK Investigational Site
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Valparaíso
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Valparaiso, Valparaíso, Chile, 2341131
- GSK Investigational Site
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Clamart, Frankrike, 92140
- GSK Investigational Site
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Marseille cedex 20, Frankrike, 13915
- GSK Investigational Site
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Montpellier, Frankrike, 34295
- GSK Investigational Site
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Nantes, Frankrike, 44093
- GSK Investigational Site
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Saint Pierre cedex, Frankrike, 97448
- GSK Investigational Site
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California
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Long Beach, California, Förenta staterna, 90808
- GSK Investigational Site
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Los Angeles, California, Förenta staterna, 90095
- GSK Investigational Site
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Riverside, California, Förenta staterna, 92506
- GSK Investigational Site
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San Diego, California, Förenta staterna, 92103-8415
- GSK Investigational Site
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Colorado
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Denver, Colorado, Förenta staterna, 80206
- GSK Investigational Site
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06510
- GSK Investigational Site
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Georgia
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Albany, Georgia, Förenta staterna, 31707
- GSK Investigational Site
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Columbus, Georgia, Förenta staterna, 31904
- GSK Investigational Site
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40508
- GSK Investigational Site
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63110
- GSK Investigational Site
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27103
- GSK Investigational Site
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Ohio
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Canton, Ohio, Förenta staterna, 44718
- GSK Investigational Site
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Cleveland, Ohio, Förenta staterna, 44195
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73103
- GSK Investigational Site
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Pennsylvania
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Hershey, Pennsylvania, Förenta staterna, 17033
- GSK Investigational Site
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Pittsburgh, Pennsylvania, Förenta staterna, PA 15213
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29406
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- GSK Investigational Site
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Texas
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Boerne, Texas, Förenta staterna, 78006
- GSK Investigational Site
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Houston, Texas, Förenta staterna, 77054
- GSK Investigational Site
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792
- GSK Investigational Site
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Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
- GSK Investigational Site
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- GSK Investigational Site
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Ontario
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Mississauga, Ontario, Kanada, L5A 3V4
- GSK Investigational Site
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Mississauga, Ontario, Kanada, L5M 2V8
- GSK Investigational Site
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Quebec
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Quebec City, Quebec, Kanada, G1V 4G5
- GSK Investigational Site
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Bucheon-si,, Korea, Republiken av, 420-767
- GSK Investigational Site
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Cheongju, Chungcheongbuk-do, Korea, Republiken av, 361-711
- GSK Investigational Site
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Seoul, Korea, Republiken av, 152-703
- GSK Investigational Site
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Seoul, Korea, Republiken av, 133--792
- GSK Investigational Site
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Suwon, Kyonggi-do, Korea, Republiken av, 443-721
- GSK Investigational Site
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Bialystok, Polen, 15-276
- GSK Investigational Site
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Lodz, Polen, 90-153
- GSK Investigational Site
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Warszawa, Polen, 01-138
- GSK Investigational Site
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Wroclaw, Polen, 54-239
- GSK Investigational Site
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Zawadzkie, Polen, 47-120
- GSK Investigational Site
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Zgierz, Polen, 95-100
- GSK Investigational Site
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Bucharest, Rumänien, 050159
- GSK Investigational Site
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Bucuresti, Rumänien, 70000
- GSK Investigational Site
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Iasi, Rumänien, 700115
- GSK Investigational Site
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Targu Mures, Rumänien, 540143
- GSK Investigational Site
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Barnaul, Ryska Federationen, 656 045
- GSK Investigational Site
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Chelyabinsk, Ryska Federationen, 454106
- GSK Investigational Site
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Kazan, Ryska Federationen, 420015
- GSK Investigational Site
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Moscow, Ryska Federationen, 105 077
- GSK Investigational Site
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Moscow, Ryska Federationen, 115478
- GSK Investigational Site
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Moscow, Ryska Federationen, 123 182
- GSK Investigational Site
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Saint-Petersburg, Ryska Federationen, 194354
- GSK Investigational Site
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St. Petersburg, Ryska Federationen, 198216
- GSK Investigational Site
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Tomsk, Ryska Federationen, 634001
- GSK Investigational Site
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London, Storbritannien, E1 2AT
- GSK Investigational Site
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London, Storbritannien, SW3 6HP
- GSK Investigational Site
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Manchester, Storbritannien, M23 9LT
- GSK Investigational Site
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Southampton, Storbritannien, SO16 6YD
- GSK Investigational Site
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Leicestershire
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Leicester, Leicestershire, Storbritannien, LE3 9QP
- GSK Investigational Site
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Berlin, Tyskland, 10367
- GSK Investigational Site
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Berlin, Tyskland, 10717
- GSK Investigational Site
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Berlin, Tyskland, 14050
- GSK Investigational Site
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Berlin, Tyskland, 12203
- GSK Investigational Site
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Brandenburg
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Ruedersdorf, Brandenburg, Tyskland, 15562
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, Tyskland, 60596
- GSK Investigational Site
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Frankfurt am Main, Hessen, Tyskland, 60596
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Tyskland, 55131
- GSK Investigational Site
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Tyskland, 39112
- GSK Investigational Site
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, Tyskland, 23552
- GSK Investigational Site
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Cherkassy, Ukraina, 18009
- GSK Investigational Site
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Dnipropetrovsk, Ukraina, 49006
- GSK Investigational Site
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Dnipropetrovsk, Ukraina, 49051
- GSK Investigational Site
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Dnipropetrovsk, Ukraina, 49027
- GSK Investigational Site
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Donetsk, Ukraina, 83003
- GSK Investigational Site
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Donetsk, Ukraina, 83099
- GSK Investigational Site
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Kharkiv, Ukraina, 61035
- GSK Investigational Site
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Kiev, Ukraina, 03680
- GSK Investigational Site
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Kyiv, Ukraina, 03038
- GSK Investigational Site
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Kyiv, Ukraina, 03115
- GSK Investigational Site
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Mykolayiv, Ukraina, 54003
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 65 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Mepolizumab 750mg
Mepolizumab 750mcg i.v.
every 4 weeks
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Mepolizumab 750mg every four weeks by i.v.
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Aktiv komparator: Mepolizumab 250mg
Mepolizumab 250mcg i.v.
every 4 weeks
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Mepolizumab 250mg every four weeks by i.v.
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Aktiv komparator: Mepolizumab 75mg
Mepolizumab 75mcg i.v.
every 4 weeks
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Mepolizumab 75mg every four weeks by i.v.
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Placebo-jämförare: Placebo
Placebo saline every 4 weeks i.v.
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Placebo saline every four weeks by i.v.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Clinically Significant Exacerbations of Asthma Per Year
Tidsram: From randomization (Week 0) to Week 52 or early withdrawal (EW)
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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
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From randomization (Week 0) to Week 52 or early withdrawal (EW)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit
Tidsram: From randomization (Week 0) to Week 52 or EW
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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).
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From randomization (Week 0) to Week 52 or EW
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Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year
Tidsram: From randomization (Week 0) to Week 52 or EW
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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.
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From randomization (Week 0) to Week 52 or EW
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Time to First Exacerbation Requiring Hospitalization or ED Visit
Tidsram: From randomization (Week 0) to Week 52 or EW
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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).
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From randomization (Week 0) to Week 52 or EW
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Number of All Recorded Exacerbations Per Year
Tidsram: From randomization (Week 0) to Week 52 or EW
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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.
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From randomization (Week 0) to Week 52 or EW
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Time to First All Recorded Exacerbation
Tidsram: From randomization (Week 0) to Week 52 or EW
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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).
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From randomization (Week 0) to Week 52 or EW
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Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period
Tidsram: From Baseline up to Week 52 or EW
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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.
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From Baseline up to Week 52 or EW
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Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period
Tidsram: From Baseline up to Week 52 or EW
|
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
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From Baseline up to Week 52 or EW
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Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period
Tidsram: From Baseline up to Week 52 or EW
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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.
|
From Baseline up to Week 52 or EW
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Pavord I, Korn S, Howarth P, Bleecker E, Buhl R, Keene O, Ortega H, Chanez P. Mepolizumab (anti-IL-5) reduces exacerbations in patients with refractory eosinophilic asthma. [Lancet]. 2012;380(August 18, 2012):
- 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2009
Primärt slutförande (Faktisk)
23 mars 2012
Avslutad studie (Faktisk)
23 mars 2012
Studieregistreringsdatum
Först inskickad
22 oktober 2009
Först inskickad som uppfyllde QC-kriterierna
22 oktober 2009
Första postat (Uppskatta)
23 oktober 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 januari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 112997
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
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Annoterad fallrapportformulär
Informationsidentifierare: 112997Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Informerat samtycke
Informationsidentifierare: 112997Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analysplan
Informationsidentifierare: 112997Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informationsidentifierare: 112997Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättning för individuella deltagare
Informationsidentifierare: 112997Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datauppsättningsspecifikation
Informationsidentifierare: 112997Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk studierapport
Informationsidentifierare: 112997Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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