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Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

23. november 2015 opdateret af: AstraZeneca

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Ciudad de Buenos Aire, Argentina
        • Research Site
  • Brasilien
      • São Paulo, Brasilien
        • Research Site
  • Bulgarien
      • Ruse, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
      • Varna, Bulgarien
        • Research Site
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation
        • Research Site
      • Ekaterinburg, Den Russiske Føderation
        • Research Site
      • Izhevsk, Den Russiske Føderation
        • Research Site
      • Kazan, Den Russiske Føderation
        • Research Site
      • Moscow, Den Russiske Føderation
        • Research Site
      • Novosibirsk, Den Russiske Føderation
        • Research Site
      • Pyatigorsk, Den Russiske Føderation
        • Research Site
      • Saint Petersburg, Den Russiske Føderation
        • Research Site
      • St. Petersburg, Den Russiske Føderation
        • Research Site
      • Ulyanovsk, Den Russiske Føderation
        • Research Site
      • Vladikavkaz, Den Russiske Føderation
        • Research Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • Research Site
    • Arizona
      • Glendale, Arizona, Forenede Stater
        • Research Site
    • California
      • San Jose, California, Forenede Stater
        • Research Site
    • Colorado
      • Centennial, Colorado, Forenede Stater
        • Research Site
    • Florida
      • Miami, Florida, Forenede Stater
        • Research Site
      • Orlando, Florida, Forenede Stater
        • Research Site
      • Pembroke Pines, Florida, Forenede Stater
        • Research Site
      • Winter Park, Florida, Forenede Stater
        • Research Site
    • Georgia
      • Lawrenceville, Georgia, Forenede Stater
        • Research Site
      • Savannah, Georgia, Forenede Stater
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, Forenede Stater
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Research Site
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater
        • Research Site
    • South Carolina
      • Rock Hill, South Carolina, Forenede Stater
        • Research Site
    • Texas
      • Arlington, Texas, Forenede Stater
        • Research Site
      • Austin, Texas, Forenede Stater
        • Research Site
      • Dallas, Texas, Forenede Stater
        • Research Site
      • San Antonio, Texas, Forenede Stater
        • Research Site
      • Sugarland, Texas, Forenede Stater
        • Research Site
  • Polen
      • Bydgoszcz, Polen
        • Research Site
      • Giżycko, Polen
        • Research Site
      • Lubin, Polen
        • Research Site
      • Ostrów Wielkopolski, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Wrocław, Polen
        • Research Site
      • Łódź, Polen
        • Research Site
      • Żnin, Polen
        • Research Site
  • Tyskland
      • Hamburg, Tyskland
        • Research Site
      • Mainz, Tyskland
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and male aged from 18 to 75 years, inclusively
  3. History of physician-diagnosed asthma requiring treatment with medium dose ICS (>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
  4. Documented treatment with medium-dose ICS (>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to Visit 1

Exclusion criteria:

  1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patient's ability to complete the entire duration of study
  3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Benra 30 mg q.4 Weeks
Fixed 30 mg dose of benralizumab (every 4 weeks)
Biologisk: Benralizumab

Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive.

Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.
Eksperimentel: Benra 30 mg - Placebo q.8 Weeks
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
Biologisk: Benralizumab

Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive.

Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.
Placebo komparator: Placebo
A (Dummy) injection
Biologisk: Placebo
Placebo subkutant i undersøgelsesuge 0 indtil undersøgelsesuge 44 inklusive.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Asthma Exacerbations Over 48 Weeks Treatment
Tidsramme: 48 weeks treatment
The number of asthma exacerbations over 48 weeks treatment will be counted
48 weeks treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Ledende efterforsker: William W. Busse, MD, Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2013

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først indsendt

11. september 2013

Først indsendt, der opfyldte QC-kriterier

18. september 2013

Først opslået (Skøn)

23. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. november 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D3250C00016

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in India

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner