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A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

11. august 2016 opdateret af: MedImmune LLC

A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects With Moderate-to-severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia

To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to [>=] 3.0 percent [%] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to placebo.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

421

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Research Site
  • Danmark
      • Hellerup, Danmark
        • Research Site
      • København NV, Danmark
        • Research Site
      • Odense C, Danmark
        • Research Site
      • Århus C, Danmark
        • Research Site
  • Det Forenede Kongerige
      • Cambridge, Det Forenede Kongerige
        • Research Site
      • Edinburgh, Det Forenede Kongerige
        • Research Site
      • Leicester, Det Forenede Kongerige
        • Research Site
      • Manchester, Det Forenede Kongerige
        • Research Site
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater
        • Research Site
    • Georgia
      • Marietta, Georgia, Forenede Stater
        • Research Site
    • Illinois
      • Normal, Illinois, Forenede Stater
        • Research Site
    • New York
      • Brooklyn, New York, Forenede Stater
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater
        • Research Site
    • Texas
      • Boerne, Texas, Forenede Stater
        • Research Site
      • Tyler, Texas, Forenede Stater
        • Research Site
    • Virginia
      • Richmond, Virginia, Forenede Stater
        • Research Site
  • Polen
      • Gdańsk, Polen
        • Research Site
      • Kraków, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Łódź, Polen
        • Research Site
  • Spanien
      • Barcelona, Spanien
        • Research Site
      • Lérida, Spanien
        • Research Site
      • Málaga, Spanien
        • Research Site
      • Oviedo, Spanien
        • Research Site
  • Tyskland
      • Frankfurt, 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

40 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects aged 40-85 years at the time of Screening
  • Written informed consent obtained from the subject prior to performing any protocol related procedures
  • Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
  • Current smoker or ex-smoker with a tobacco history of greater than or equal to (>=) 10 pack-years
  • Adequate contraception from screening through end of trial
  • Able to read and write.

Exclusion Criteria:

  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
  • Pregnant, breastfeeding, or lactating women
  • Known history of allergy or reaction to any component of the investigational product formulation
  • History of anaphylaxis to any other biologic therapy
  • Donation or transfusion of blood, plasma or platelets within the past 3 months prior to Screening
  • Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study
  • Fever greater than (>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening
  • Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study
  • Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus 1or 2 (HIV-1 or HIV 2)
  • History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation
  • Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to Screening
  • Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)
  • Current diagnosis of asthma according to Global Initiative for Asthma guidelines
  • Previous treatment with MEDI-563.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Andet: Placebo
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Eksperimentel: Benralizumab 100 mg
Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Biologisk: Benralizumab 100 mg
Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Andre navne:
  • MEDI-563

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tidsramme: Day 1 up to 393
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.
Day 1 up to 393

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Tidsramme: Day 1 up to 561
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.
Day 1 up to 561
Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tidsramme: Day 1 up to 393
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Day 1 up to 393
Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tidsramme: Day 1 up to 393
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Day 1 up to 393
Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Tidsramme: Day 1 up to 393
An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.
Day 1 up to 393
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Tidsramme: Baseline, Day 393
The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
Baseline, Day 393
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Tidsramme: Day 393
SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.
Day 393
Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Tidsramme: Baseline, Day 393
The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).
Baseline, Day 393
Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Tidsramme: Day 393
The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.
Day 393
Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393
Tidsramme: Baseline, Day 393
The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
Baseline, Day 393

Samarbejdspartnere og efterforskere

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

Sponsor

MedImmune LLC

Samarbejdspartnere

AstraZeneca

Efterforskere

  • Studieleder: Rene van der Merwe, MBChB, MedImmune Ltd

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 2010

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

21. oktober 2010

Først indsendt, der opfyldte QC-kriterier

22. oktober 2010

Først opslået (Skøn)

25. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. august 2016

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MI-CP196
  • 2010-020127-52 (EudraCT nummer)

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 .

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