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Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

30. november 2016 opdateret af: AstraZeneca

A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
2508

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • 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
      • Caba, Argentina
        • Research Site
      • Ciudad Autónoma de Bs. As., Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Concepción del Uruguay, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Florida, Argentina
        • Research Site
      • Godoy Cruz, Argentina
        • Research Site
      • La Plata, Argentina
        • Research Site
      • Mar del Plata, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • Ranelagh, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • San Miguel de Tucuman, Argentina
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Sherwood Park, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • St Charles Borromee, Quebec, Canada
        • Research Site
  • Chile
      • Concepcion, Chile
        • Research Site
      • Quillota, Chile
        • Research Site
      • Santiago, Chile
        • Research Site
      • Talcahuano, Chile
        • Research Site
      • Valparaiso, Chile
        • Research Site
      • Viña del Mar, Chile
        • Research Site
  • Filippinerne
      • Iloilo City, Filippinerne
        • Research Site
      • Lipa City, Filippinerne
        • Research Site
      • Quezon City, Filippinerne
        • Research Site
  • Forenede Stater
    • Alabama
      • Andalusia, Alabama, Forenede Stater
        • Research Site
      • Birmingham, Alabama, Forenede Stater
        • Research Site
    • Arizona
      • Flagstaff, Arizona, Forenede Stater
        • Research Site
      • Glendale, Arizona, Forenede Stater
        • Research Site
      • Phoenix, Arizona, Forenede Stater
        • Research Site
      • Tucson, Arizona, Forenede Stater
        • Research Site
    • California
      • Alhambra, California, Forenede Stater
        • Research Site
      • Anaheim, California, Forenede Stater
        • Research Site
      • Beverly Hills, California, Forenede Stater
        • Research Site
      • Garden Grove, California, Forenede Stater
        • Research Site
      • Lakewood, California, Forenede Stater
        • Research Site
      • North Hollywood, California, Forenede Stater
        • Research Site
      • Northridge, California, Forenede Stater
        • Research Site
      • Palmdale, California, Forenede Stater
        • Research Site
      • Rancho Mirage, California, Forenede Stater
        • Research Site
      • Redondo Beach, California, Forenede Stater
        • Research Site
      • Rolling Hills Estate, California, Forenede Stater
        • Research Site
      • Sacramento, California, Forenede Stater
        • Research Site
      • Stockton, California, Forenede Stater
        • Research Site
      • Thousand Oaks, California, Forenede Stater
        • Research Site
      • Upland, California, Forenede Stater
        • Research Site
      • Ventura, California, Forenede Stater
        • Research Site
      • Walnut Creek, California, Forenede Stater
        • Research Site
      • Westminister, California, Forenede Stater
        • Research Site
      • Woodland, California, Forenede Stater
        • Research Site
    • Colorado
      • Centennial, Colorado, Forenede Stater
        • Research Site
      • Colorado Springs, Colorado, Forenede Stater
        • Research Site
      • Wheat Ridge, Colorado, Forenede Stater
        • Research Site
    • Florida
      • Celebration, Florida, Forenede Stater
        • Research Site
      • Fort Lauderdale, Florida, Forenede Stater
        • Research Site
      • Hialeah, Florida, Forenede Stater
        • Research Site
      • Homestead, Florida, Forenede Stater
        • Research Site
      • Jacksonville, Florida, Forenede Stater
        • Research Site
      • Lehigh Acres, Florida, Forenede Stater
        • Research Site
      • Miami, Florida, Forenede Stater
        • Research Site
      • Ocala, Florida, Forenede Stater
        • Research Site
      • Orlando, Florida, Forenede Stater
        • Research Site
      • Ormond Beach, Florida, Forenede Stater
        • Research Site
      • Virginia Gardens, Florida, Forenede Stater
        • Research Site
    • Georgia
      • Gainesville, Georgia, Forenede Stater
        • Research Site
      • Smyrna, Georgia, Forenede Stater
        • Research Site
    • Idaho
      • Eagle, Idaho, Forenede Stater
        • Research Site
    • Illinois
      • Shiloh, Illinois, Forenede Stater
        • Research Site
    • Kansas
      • Lenexa, Kansas, Forenede Stater
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, Forenede Stater
        • Research Site
    • Louisiana
      • Covington, Louisiana, Forenede Stater
        • Research Site
    • Maine
      • Bangor, Maine, Forenede Stater
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Forenede Stater
        • Research Site
      • Flint, Michigan, Forenede Stater
        • Research Site
      • Traverse City, Michigan, Forenede Stater
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater
        • Research Site
    • Missouri
      • St Louis, Missouri, Forenede Stater
        • Research Site
    • Nevada
      • Las Vagas, Nevada, Forenede Stater
        • Research Site
    • New Jersey
      • Union, New Jersey, Forenede Stater
        • Research Site
    • New York
      • Bronx, New York, Forenede Stater
        • Research Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater
        • Research Site
      • Wilmington, North Carolina, Forenede Stater
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
        • Research Site
      • Columbus, Ohio, Forenede Stater
        • Research Site
      • Dayton, Ohio, Forenede Stater
        • Research Site
      • Middleburg Heights, Ohio, Forenede Stater
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Research Site
    • Oregon
      • Corvallis, Oregon, Forenede Stater
        • Research Site
      • Portland, Oregon, Forenede Stater
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Forenede Stater
        • Research Site
      • Pittsburgh, Pennsylvania, Forenede Stater
        • Research Site
    • South Carolina
      • Indian Land, South Carolina, Forenede Stater
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater
        • Research Site
    • Texas
      • Arlington, Texas, Forenede Stater
        • Research Site
      • Austin, Texas, Forenede Stater
        • Research Site
      • Boerne, Texas, Forenede Stater
        • Research Site
      • Dallas, Texas, Forenede Stater
        • Research Site
      • Houston, Texas, Forenede Stater
        • Research Site
      • San Antonio, Texas, Forenede Stater
        • Research Site
    • Utah
      • Midvale, Utah, Forenede Stater
        • Research Site
      • Murray, Utah, Forenede Stater
        • Research Site
    • Virginia
      • Fairfax, Virginia, Forenede Stater
        • Research Site
      • Falls Church, Virginia, Forenede Stater
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater
        • Research Site
      • Milwaukee, Wisconsin, Forenede Stater
        • Research Site
  • Japan
      • Asahi-shi, Japan
        • Research Site
      • Chiyoda-ku, Japan
        • Research Site
      • Chuo-ku, Japan
        • Research Site
      • Fukuoka-shi, Japan
        • Research Site
      • Himeji-shi, Japan
        • Research Site
      • Hiroshima-shi, Japan
        • Research Site
      • Itabashi-ku, Japan
        • Research Site
      • Kagoshima-shi, Japan
        • Research Site
      • Kishiwada-shi, Japan
        • Research Site
      • Kobe-shi, Japan
        • Research Site
      • Kokubunji-shi, Japan
        • Research Site
      • Matsue-shi, Japan
        • Research Site
      • Minato-ku, Japan
        • Research Site
      • Mizunami-shi, Japan
        • Research Site
      • Niigata-shi, Japan
        • Research Site
      • Obihiro-shi, Japan
        • Research Site
      • Oita-shi, Japan
        • Research Site
      • Ota-shi, Japan
        • Research Site
      • Sagamihara-shi, Japan
        • Research Site
      • Sakai-shi, Japan
        • Research Site
      • Sakaide-shi, Japan
        • Research Site
      • Sapporo-shi, Japan
        • Research Site
      • Sendai-shi, Japan
        • Research Site
      • Setagaya-ku, Japan
        • Research Site
      • Shibuya-ku, Japan
        • Research Site
      • Shinagawa-ku, Japan
        • Research Site
      • Sumida-ku, Japan
        • Research Site
      • Takamatsu-shi, Japan
        • Research Site
      • Toshima-ku, Japan
        • Research Site
      • Tsukubo-gun, Japan
        • Research Site
      • Yokohama-shi, Japan
        • Research Site
  • Polen
      • Aleksandrów Łódzki, Polen
        • Research Site
      • Białystok, Polen
        • Research Site
      • Bielsko Biala, Polen
        • Research Site
      • Bydgoszcz, Polen
        • Research Site
      • Bystra Śląska, Polen
        • Research Site
      • Gdańsk, Polen
        • Research Site
      • Gorzów Wlkp, Polen
        • Research Site
      • Karczew, Polen
        • Research Site
      • Katowice, Polen
        • Research Site
      • Koszalin, Polen
        • Research Site
      • Kraków, Polen
        • Research Site
      • Lubin, Polen
        • Research Site
      • Lublin, Polen
        • Research Site
      • Ostrów Wielkopolski, Polen
        • Research Site
      • Poznań, Polen
        • Research Site
      • Ruda Slaska, Polen
        • Research Site
      • Rzeszów, Polen
        • Research Site
      • Skierniewice, Polen
        • Research Site
      • Szczecin, Polen
        • Research Site
      • Tarnów, Polen
        • Research Site
      • Toruń, Polen
        • Research Site
      • Trzebnica, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Wieluń, Polen
        • Research Site
      • Wroclaw, Polen
        • Research Site
      • Wrocław, Polen
        • Research Site
      • Zabrze, Polen
        • Research Site
      • Łódź, Polen
        • Research Site
      • Łęczna, Polen
        • Research Site
      • Żnin, Polen
        • Research Site
  • Rumænien
      • Bragadiru, Rumænien
        • Research Site
      • Brasov, Rumænien
        • Research Site
      • Bucharest, Rumænien
        • Research Site
      • Constanta, Rumænien
        • Research Site
      • Deva, Rumænien
        • Research Site
      • Iasi, Rumænien
        • Research Site
      • Timisoara, Rumænien
        • Research Site
  • Sverige
      • Goteborg, Sverige
        • Research Site
      • Luleå, Sverige
        • Research Site
      • Lund, Sverige
        • Research Site
  • Tyskland
      • Aschaffenburg, Tyskland
        • Research Site
      • Bamberg, Tyskland
        • Research Site
      • Berlin, Tyskland
        • Research Site
      • Bonn, Tyskland
        • Research Site
      • Frankfurt, Tyskland
        • Research Site
      • Frankfurt/Main, Tyskland
        • Research Site
      • Geesthacht, Tyskland
        • Research Site
      • Gelsenkirchen, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Hannover, Tyskland
        • Research Site
      • Herford, Tyskland
        • Research Site
      • Leipzig, Tyskland
        • Research Site
      • Mainz, Tyskland
        • Research Site
      • München, Tyskland
        • Research Site
      • Neu-Isenburg, Tyskland
        • Research Site
      • Rostock, Tyskland
        • Research Site
      • Rüdersdorf, Tyskland
        • Research Site
      • Witten, Tyskland
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine
        • Research Site
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lutsk, Ukraine
        • Research Site
      • Mykolayiv, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
      • Vinnytsia, Ukraine
        • Research Site
      • Vinnytsya, Ukraine
        • Research Site
      • Zaporizhzhia, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • 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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

12 år til 75 år (Barn, 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 12 to 75 years, inclusively, at the time of Visit 1
  3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
  4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

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

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Benralizumab 30 mg q.4 uger
Benralizumab administreret subkutant hver 4. uge
Biologisk: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Eksperimentel: Benralizumab 30 mg q.8 uger
Benralizumab administreret subkutant hver 8. uge
Biologisk: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo komparator: Placebo
Placebo administreret subkutant
Biologisk: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Change in Asthma Rescue Medication Use
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
Immediately following the first administration of study drug through Study Week 56.
Home Lung Function Assessments Based on PEF
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])
Immediately following the first administration of study drug through Study Week 56.
Proportion of Nights With Awakening Due to Asthma
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Number of Patients With >=1 Asthma Exacerbation
Tidsramme: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Time to First Asthma Exacerbation
Tidsramme: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
Tidsramme: Immediately following the first administration of study drug through Study Week 56.
Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)
Immediately following the first administration of study drug through Study Week 56.
Pharmacokinetics of Benralizumab
Tidsramme: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Mean PK Concentration at each visit
Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Immunogenicity of Benralizumab
Tidsramme: Pre-treatment until end of follow-up
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Pre-treatment until end of follow-up
Extent of Exposure
Tidsramme: Immediately following the first administration of study drug through Study Week 56
Extent of exposure is defined as the duration of treatment in days
Immediately following the first administration of study drug through Study Week 56
Mean Change From Baseline to Week 56 in AQLQ(S)+12
Tidsramme: Immediately following the first administration of study drug through Study Week 56
AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.
Immediately following the first administration of study drug through Study Week 56
Change From Baseline to Week 56 in EQ-5D-5L VAS
Tidsramme: Immediately following the first administration of study drug through Study Week 56
EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
Immediately following the first administration of study drug through Study Week 56
Mean Work Productivity Loss Due to Asthma
Tidsramme: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.
Immediately following the first administration of study drug through Study Week 56
Mean Productivity Loss Due to Asthma in Classroom
Tidsramme: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.
Immediately following the first administration of study drug through Study Week 56
Number of Participants That Utilized Health Care Resources
Tidsramme: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Patient and Clinician Assessment of Response to Treatment
Tidsramme: Immediately following the first administration of study drug through Study Week 56
CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.
Immediately following the first administration of study drug through Study Week 56

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
AstraZeneca

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Mark Fitzgerald, MD, PhD, Professor of Medicine, The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

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

Hjælpsomme links

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

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. august 2013

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. marts 2016

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. marts 2016

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
31. juli 2013

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
31. juli 2013

Først opslået (Skøn)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
2. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
25. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
30. november 2016

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • D3250C00018

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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