Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)

18. januar 2018 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

621

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
      • Tucuman, Argentina, 4000
        • GSK Investigational Site
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • GSK Investigational Site
  • Australia
    • New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5A 3V4
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L5M 2V8
        • GSK Investigational Site
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8380453
        • GSK Investigational Site
      • Talcahuano, Chile, 4270918
        • GSK Investigational Site
    • Región Metro De Santiago
      • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
        • GSK Investigational Site
    • Valparaíso
      • Valparaiso, Valparaíso, Chile, 2341131
        • GSK Investigational Site
  • Den russiske føderasjonen
      • Barnaul, Den russiske føderasjonen, 656 045
        • GSK Investigational Site
      • Chelyabinsk, Den russiske føderasjonen, 454106
        • GSK Investigational Site
      • Kazan, Den russiske føderasjonen, 420015
        • GSK Investigational Site
      • Moscow, Den russiske føderasjonen, 105 077
        • GSK Investigational Site
      • Moscow, Den russiske føderasjonen, 115478
        • GSK Investigational Site
      • Moscow, Den russiske føderasjonen, 123 182
        • GSK Investigational Site
      • Saint-Petersburg, Den russiske føderasjonen, 194354
        • GSK Investigational Site
      • St. Petersburg, Den russiske føderasjonen, 198216
        • GSK Investigational Site
      • Tomsk, Den russiske føderasjonen, 634001
        • GSK Investigational Site
  • Forente stater
    • California
      • Long Beach, California, Forente stater, 90808
        • GSK Investigational Site
      • Los Angeles, California, Forente stater, 90095
        • GSK Investigational Site
      • Riverside, California, Forente stater, 92506
        • GSK Investigational Site
      • San Diego, California, Forente stater, 92103-8415
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, Forente stater, 80206
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06510
        • GSK Investigational Site
    • Georgia
      • Albany, Georgia, Forente stater, 31707
        • GSK Investigational Site
      • Columbus, Georgia, Forente stater, 31904
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40508
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • GSK Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27103
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, Forente stater, 44718
        • GSK Investigational Site
      • Cleveland, Ohio, Forente stater, 44195
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • GSK Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater, 17033
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forente stater, PA 15213
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29406
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • GSK Investigational Site
    • Texas
      • Boerne, Texas, Forente stater, 78006
        • GSK Investigational Site
      • Houston, Texas, Forente stater, 77054
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • GSK Investigational Site
  • Frankrike
      • Clamart, Frankrike, 92140
        • GSK Investigational Site
      • Marseille cedex 20, Frankrike, 13915
        • GSK Investigational Site
      • Montpellier, Frankrike, 34295
        • GSK Investigational Site
      • Nantes, Frankrike, 44093
        • GSK Investigational Site
      • Saint Pierre cedex, Frankrike, 97448
        • GSK Investigational Site
  • Korea, Republikken
      • Bucheon-si,, Korea, Republikken, 420-767
        • GSK Investigational Site
      • Cheongju, Chungcheongbuk-do, Korea, Republikken, 361-711
        • GSK Investigational Site
      • Seoul, Korea, Republikken, 152-703
        • GSK Investigational Site
      • Seoul, Korea, Republikken, 133--792
        • GSK Investigational Site
      • Suwon, Kyonggi-do, Korea, Republikken, 443-721
        • GSK Investigational Site
  • Polen
      • Bialystok, Polen, 15-276
        • GSK Investigational Site
      • Lodz, Polen, 90-153
        • GSK Investigational Site
      • Warszawa, Polen, 01-138
        • GSK Investigational Site
      • Wroclaw, Polen, 54-239
        • GSK Investigational Site
      • Zawadzkie, Polen, 47-120
        • GSK Investigational Site
      • Zgierz, Polen, 95-100
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 050159
        • GSK Investigational Site
      • Bucuresti, Romania, 70000
        • GSK Investigational Site
      • Iasi, Romania, 700115
        • GSK Investigational Site
      • Targu Mures, Romania, 540143
        • GSK Investigational Site
  • Storbritannia
      • London, Storbritannia, E1 2AT
        • GSK Investigational Site
      • London, Storbritannia, SW3 6HP
        • GSK Investigational Site
      • Manchester, Storbritannia, M23 9LT
        • GSK Investigational Site
      • Southampton, Storbritannia, SO16 6YD
        • GSK Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, Storbritannia, LE3 9QP
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 10367
        • GSK Investigational Site
      • Berlin, Tyskland, 10717
        • GSK Investigational Site
      • Berlin, Tyskland, 14050
        • GSK Investigational Site
      • Berlin, Tyskland, 12203
        • GSK Investigational Site
    • Brandenburg
      • Ruedersdorf, Brandenburg, Tyskland, 15562
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Tyskland, 60596
        • GSK Investigational Site
      • Frankfurt am Main, Hessen, Tyskland, 60596
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Tyskland, 55131
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Tyskland, 39112
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Tyskland, 23552
        • GSK Investigational Site
  • Ukraina
      • Cherkassy, Ukraina, 18009
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraina, 49006
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraina, 49051
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraina, 49027
        • GSK Investigational Site
      • Donetsk, Ukraina, 83003
        • GSK Investigational Site
      • Donetsk, Ukraina, 83099
        • GSK Investigational Site
      • Kharkiv, Ukraina, 61035
        • GSK Investigational Site
      • Kiev, Ukraina, 03680
        • GSK Investigational Site
      • Kyiv, Ukraina, 03038
        • GSK Investigational Site
      • Kyiv, Ukraina, 03115
        • GSK Investigational Site
      • Mykolayiv, Ukraina, 54003
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 65 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Mepolizumab 750mg
Mepolizumab 750mcg i.v. every 4 weeks
Biologisk: Mepolizumab 750
Mepolizumab 750mg every four weeks by i.v.
Aktiv komparator: Mepolizumab 250mg
Mepolizumab 250mcg i.v. every 4 weeks
Biologisk: Mepolizumab 250
Mepolizumab 250mg every four weeks by i.v.
Aktiv komparator: Mepolizumab 75mg
Mepolizumab 75mcg i.v. every 4 weeks
Biologisk: Mepolizumab 75
Mepolizumab 75mg every four weeks by i.v.
Placebo komparator: Placebo
Placebo saline every 4 weeks i.v.
Legemiddel: Placebo saline
Placebo saline every four weeks by i.v.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Clinically Significant Exacerbations of Asthma Per Year
Tidsramme: From randomization (Week 0) to Week 52 or early withdrawal (EW)
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
From randomization (Week 0) to Week 52 or early withdrawal (EW)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit
Tidsramme: From randomization (Week 0) to Week 52 or EW
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).
From randomization (Week 0) to Week 52 or EW
Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year
Tidsramme: From randomization (Week 0) to Week 52 or EW
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.
From randomization (Week 0) to Week 52 or EW
Time to First Exacerbation Requiring Hospitalization or ED Visit
Tidsramme: From randomization (Week 0) to Week 52 or EW
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).
From randomization (Week 0) to Week 52 or EW
Number of All Recorded Exacerbations Per Year
Tidsramme: From randomization (Week 0) to Week 52 or EW
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.
From randomization (Week 0) to Week 52 or EW
Time to First All Recorded Exacerbation
Tidsramme: From randomization (Week 0) to Week 52 or EW
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).
From randomization (Week 0) to Week 52 or EW
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period
Tidsramme: From Baseline up to Week 52 or EW
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.
From Baseline up to Week 52 or EW
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period
Tidsramme: 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
From Baseline up to Week 52 or EW
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period
Tidsramme: From Baseline up to Week 52 or EW
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2009

Primær fullføring (Faktiske)

23. mars 2012

Studiet fullført (Faktiske)

23. mars 2012

Datoer for studieregistrering

Først innsendt

22. oktober 2009

Først innsendt som oppfylte QC-kriteriene

22. oktober 2009

Først lagt ut (Anslag)

23. oktober 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 112997

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Annotert saksrapportskjema
    Informasjonsidentifikator: 112997
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Skjema for informert samtykke
    Informasjonsidentifikator: 112997
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informasjonsidentifikator: 112997
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Studieprotokoll
    Informasjonsidentifikator: 112997
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasett for individuell deltaker
    Informasjonsidentifikator: 112997
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasettspesifikasjon
    Informasjonsidentifikator: 112997
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk studierapport
    Informasjonsidentifikator: 112997
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Mepolizumab 750

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Sweden

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere