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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. listopadu 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

2508

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • 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
  • 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
  • Filipíny
      • Iloilo City, Filipíny
        • Research Site
      • Lipa City, Filipíny
        • Research Site
      • Quezon City, Filipíny
        • Research Site
  • Japonsko
      • Asahi-shi, Japonsko
        • Research Site
      • Chiyoda-ku, Japonsko
        • Research Site
      • Chuo-ku, Japonsko
        • Research Site
      • Fukuoka-shi, Japonsko
        • Research Site
      • Himeji-shi, Japonsko
        • Research Site
      • Hiroshima-shi, Japonsko
        • Research Site
      • Itabashi-ku, Japonsko
        • Research Site
      • Kagoshima-shi, Japonsko
        • Research Site
      • Kishiwada-shi, Japonsko
        • Research Site
      • Kobe-shi, Japonsko
        • Research Site
      • Kokubunji-shi, Japonsko
        • Research Site
      • Matsue-shi, Japonsko
        • Research Site
      • Minato-ku, Japonsko
        • Research Site
      • Mizunami-shi, Japonsko
        • Research Site
      • Niigata-shi, Japonsko
        • Research Site
      • Obihiro-shi, Japonsko
        • Research Site
      • Oita-shi, Japonsko
        • Research Site
      • Ota-shi, Japonsko
        • Research Site
      • Sagamihara-shi, Japonsko
        • Research Site
      • Sakai-shi, Japonsko
        • Research Site
      • Sakaide-shi, Japonsko
        • Research Site
      • Sapporo-shi, Japonsko
        • Research Site
      • Sendai-shi, Japonsko
        • Research Site
      • Setagaya-ku, Japonsko
        • Research Site
      • Shibuya-ku, Japonsko
        • Research Site
      • Shinagawa-ku, Japonsko
        • Research Site
      • Sumida-ku, Japonsko
        • Research Site
      • Takamatsu-shi, Japonsko
        • Research Site
      • Toshima-ku, Japonsko
        • Research Site
      • Tsukubo-gun, Japonsko
        • Research Site
      • Yokohama-shi, Japonsko
        • Research Site
  • Kanada
      • Quebec, Kanada
        • Research Site
    • Alberta
      • Calgary, Alberta, Kanada
        • Research Site
      • Sherwood Park, Alberta, Kanada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Kanada
        • Research Site
    • Ontario
      • Burlington, Ontario, Kanada
        • Research Site
      • Hamilton, Ontario, Kanada
        • Research Site
      • Ottawa, Ontario, Kanada
        • Research Site
      • Toronto, Ontario, Kanada
        • Research Site
    • Quebec
      • Montreal, Quebec, Kanada
        • Research Site
      • St Charles Borromee, Quebec, Kanada
        • Research Site
  • Německo
      • Aschaffenburg, Německo
        • Research Site
      • Bamberg, Německo
        • Research Site
      • Berlin, Německo
        • Research Site
      • Bonn, Německo
        • Research Site
      • Frankfurt, Německo
        • Research Site
      • Frankfurt/Main, Německo
        • Research Site
      • Geesthacht, Německo
        • Research Site
      • Gelsenkirchen, Německo
        • Research Site
      • Hamburg, Německo
        • Research Site
      • Hannover, Německo
        • Research Site
      • Herford, Německo
        • Research Site
      • Leipzig, Německo
        • Research Site
      • Mainz, Německo
        • Research Site
      • München, Německo
        • Research Site
      • Neu-Isenburg, Německo
        • Research Site
      • Rostock, Německo
        • Research Site
      • Rüdersdorf, Německo
        • Research Site
      • Witten, Německo
        • Research Site
  • Polsko
      • Aleksandrów Łódzki, Polsko
        • Research Site
      • Białystok, Polsko
        • Research Site
      • Bielsko Biala, Polsko
        • Research Site
      • Bydgoszcz, Polsko
        • Research Site
      • Bystra Śląska, Polsko
        • Research Site
      • Gdańsk, Polsko
        • Research Site
      • Gorzów Wlkp, Polsko
        • Research Site
      • Karczew, Polsko
        • Research Site
      • Katowice, Polsko
        • Research Site
      • Koszalin, Polsko
        • Research Site
      • Kraków, Polsko
        • Research Site
      • Lubin, Polsko
        • Research Site
      • Lublin, Polsko
        • Research Site
      • Ostrów Wielkopolski, Polsko
        • Research Site
      • Poznań, Polsko
        • Research Site
      • Ruda Slaska, Polsko
        • Research Site
      • Rzeszów, Polsko
        • Research Site
      • Skierniewice, Polsko
        • Research Site
      • Szczecin, Polsko
        • Research Site
      • Tarnów, Polsko
        • Research Site
      • Toruń, Polsko
        • Research Site
      • Trzebnica, Polsko
        • Research Site
      • Warszawa, Polsko
        • Research Site
      • Wieluń, Polsko
        • Research Site
      • Wroclaw, Polsko
        • Research Site
      • Wrocław, Polsko
        • Research Site
      • Zabrze, Polsko
        • Research Site
      • Łódź, Polsko
        • Research Site
      • Łęczna, Polsko
        • Research Site
      • Żnin, Polsko
        • Research Site
  • Rumunsko
      • Bragadiru, Rumunsko
        • Research Site
      • Brasov, Rumunsko
        • Research Site
      • Bucharest, Rumunsko
        • Research Site
      • Constanta, Rumunsko
        • Research Site
      • Deva, Rumunsko
        • Research Site
      • Iasi, Rumunsko
        • Research Site
      • Timisoara, Rumunsko
        • Research Site
  • Spojené státy
    • Alabama
      • Andalusia, Alabama, Spojené státy
        • Research Site
      • Birmingham, Alabama, Spojené státy
        • Research Site
    • Arizona
      • Flagstaff, Arizona, Spojené státy
        • Research Site
      • Glendale, Arizona, Spojené státy
        • Research Site
      • Phoenix, Arizona, Spojené státy
        • Research Site
      • Tucson, Arizona, Spojené státy
        • Research Site
    • California
      • Alhambra, California, Spojené státy
        • Research Site
      • Anaheim, California, Spojené státy
        • Research Site
      • Beverly Hills, California, Spojené státy
        • Research Site
      • Garden Grove, California, Spojené státy
        • Research Site
      • Lakewood, California, Spojené státy
        • Research Site
      • North Hollywood, California, Spojené státy
        • Research Site
      • Northridge, California, Spojené státy
        • Research Site
      • Palmdale, California, Spojené státy
        • Research Site
      • Rancho Mirage, California, Spojené státy
        • Research Site
      • Redondo Beach, California, Spojené státy
        • Research Site
      • Rolling Hills Estate, California, Spojené státy
        • Research Site
      • Sacramento, California, Spojené státy
        • Research Site
      • Stockton, California, Spojené státy
        • Research Site
      • Thousand Oaks, California, Spojené státy
        • Research Site
      • Upland, California, Spojené státy
        • Research Site
      • Ventura, California, Spojené státy
        • Research Site
      • Walnut Creek, California, Spojené státy
        • Research Site
      • Westminister, California, Spojené státy
        • Research Site
      • Woodland, California, Spojené státy
        • Research Site
    • Colorado
      • Centennial, Colorado, Spojené státy
        • Research Site
      • Colorado Springs, Colorado, Spojené státy
        • Research Site
      • Wheat Ridge, Colorado, Spojené státy
        • Research Site
    • Florida
      • Celebration, Florida, Spojené státy
        • Research Site
      • Fort Lauderdale, Florida, Spojené státy
        • Research Site
      • Hialeah, Florida, Spojené státy
        • Research Site
      • Homestead, Florida, Spojené státy
        • Research Site
      • Jacksonville, Florida, Spojené státy
        • Research Site
      • Lehigh Acres, Florida, Spojené státy
        • Research Site
      • Miami, Florida, Spojené státy
        • Research Site
      • Ocala, Florida, Spojené státy
        • Research Site
      • Orlando, Florida, Spojené státy
        • Research Site
      • Ormond Beach, Florida, Spojené státy
        • Research Site
      • Virginia Gardens, Florida, Spojené státy
        • Research Site
    • Georgia
      • Gainesville, Georgia, Spojené státy
        • Research Site
      • Smyrna, Georgia, Spojené státy
        • Research Site
    • Idaho
      • Eagle, Idaho, Spojené státy
        • Research Site
    • Illinois
      • Shiloh, Illinois, Spojené státy
        • Research Site
    • Kansas
      • Lenexa, Kansas, Spojené státy
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, Spojené státy
        • Research Site
    • Louisiana
      • Covington, Louisiana, Spojené státy
        • Research Site
    • Maine
      • Bangor, Maine, Spojené státy
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Spojené státy
        • Research Site
      • Flint, Michigan, Spojené státy
        • Research Site
      • Traverse City, Michigan, Spojené státy
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Spojené státy
        • Research Site
    • Missouri
      • St Louis, Missouri, Spojené státy
        • Research Site
    • Nevada
      • Las Vagas, Nevada, Spojené státy
        • Research Site
    • New Jersey
      • Union, New Jersey, Spojené státy
        • Research Site
    • New York
      • Bronx, New York, Spojené státy
        • Research Site
    • North Carolina
      • Durham, North Carolina, Spojené státy
        • Research Site
      • Wilmington, North Carolina, Spojené státy
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Spojené státy
        • Research Site
      • Columbus, Ohio, Spojené státy
        • Research Site
      • Dayton, Ohio, Spojené státy
        • Research Site
      • Middleburg Heights, Ohio, Spojené státy
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy
        • Research Site
    • Oregon
      • Corvallis, Oregon, Spojené státy
        • Research Site
      • Portland, Oregon, Spojené státy
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Spojené státy
        • Research Site
      • Pittsburgh, Pennsylvania, Spojené státy
        • Research Site
    • South Carolina
      • Indian Land, South Carolina, Spojené státy
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, Spojené státy
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, Spojené státy
        • Research Site
    • Texas
      • Arlington, Texas, Spojené státy
        • Research Site
      • Austin, Texas, Spojené státy
        • Research Site
      • Boerne, Texas, Spojené státy
        • Research Site
      • Dallas, Texas, Spojené státy
        • Research Site
      • Houston, Texas, Spojené státy
        • Research Site
      • San Antonio, Texas, Spojené státy
        • Research Site
    • Utah
      • Midvale, Utah, Spojené státy
        • Research Site
      • Murray, Utah, Spojené státy
        • Research Site
    • Virginia
      • Fairfax, Virginia, Spojené státy
        • Research Site
      • Falls Church, Virginia, Spojené státy
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Spojené státy
        • Research Site
      • Milwaukee, Wisconsin, Spojené státy
        • Research Site
  • Ukrajina
      • Chernivtsi, Ukrajina
        • Research Site
      • Dnipropetrovsk, Ukrajina
        • Research Site
      • Ivano-Frankivsk, Ukrajina
        • Research Site
      • Kharkiv, Ukrajina
        • Research Site
      • Kyiv, Ukrajina
        • Research Site
      • Lutsk, Ukrajina
        • Research Site
      • Mykolayiv, Ukrajina
        • Research Site
      • Uzhgorod, Ukrajina
        • Research Site
      • Vinnytsia, Ukrajina
        • Research Site
      • Vinnytsya, Ukrajina
        • Research Site
      • Zaporizhzhia, Ukrajina
        • Research Site
      • Zaporozhye, Ukrajina
        • Research Site
  • Švédsko
      • Goteborg, Švédsko
        • Research Site
      • Luleå, Švédsko
        • Research Site
      • Lund, Švédsko
        • Research Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let až 75 let (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Benralizumab 30 mg q.4 týdny
Benralizumab podávaný subkutánně každé 4 týdny
Biologický: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Experimentální: Benralizumab 30 mg každých 8 týdnů
Benralizumab podávaný subkutánně každých 8 týdnů
Biologický: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Komparátor placeba: Placebo
Placebo podávané subkutánně
Biologický: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AstraZeneca

Vyšetřovatelé

  • Vrchní vyšetřovatel: Mark Fitzgerald, MD, PhD, Professor of Medicine, The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. srpna 2013

Primární dokončení (Aktuální)

1. března 2016

Dokončení studie (Aktuální)

1. března 2016

Termíny zápisu do studia

První předloženo

31. července 2013

První předloženo, které splnilo kritéria kontroly kvality

31. července 2013

První zveřejněno (Odhad)

2. srpna 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

25. ledna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. listopadu 2016

Naposledy ověřeno

1. listopadu 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • D3250C00018

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Benralizumab

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

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Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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