此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2016年11月30日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

2508

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 75年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Benralizumab 30 mg 每 4 周一次
贝那利珠单抗每 4 周皮下注射一次
生物：Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
实验性的：贝那利珠单抗 30 mg 每 8 周一次
贝那利珠单抗每 8 周皮下注射一次
生物：Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
安慰剂比较：安慰剂
安慰剂皮下给药
生物：Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

调查人员

  • 首席研究员：Mark Fitzgerald, MD, PhD, Professor of Medicine、The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年8月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2013年7月31日

首先提交符合 QC 标准的

2013年7月31日

首次发布 (估计)

2013年8月2日

研究记录更新

最后更新发布 (估计)

2017年1月25日

上次提交的符合 QC 标准的更新

2016年11月30日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D3250C00018

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅