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Cross-sectional Study for Identification and Description of Severe Asthma Patients

2016年3月31日 更新者：GlaxoSmithKline

Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study

This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.

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)

767

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

  • 加拿大
    • Alberta
      • Sherwood Park、Alberta、加拿大、T8H 0N2
        • GSK Investigational Site
    • Ontario
      • Brampton、Ontario、加拿大、L6T 0G1
        • GSK Investigational Site
      • Burlington、Ontario、加拿大、L7N 3V2
        • GSK Investigational Site
      • Grimsby、Ontario、加拿大、L3M1P3
        • GSK Investigational Site
      • London、Ontario、加拿大、N6A1V2
        • GSK Investigational Site
      • Mississauga、Ontario、加拿大、L5A 3V4
        • GSK Investigational Site
      • St-Charles-Borromée、Ontario、加拿大、J6E 2B4
        • GSK Investigational Site
      • Toronto、Ontario、加拿大、M5G 1E2
        • GSK Investigational Site
      • Toronto、Ontario、加拿大、M5T 3A9
        • GSK Investigational Site
      • Windsor、Ontario、加拿大、N8X2G1
        • GSK Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大、H4J 1C5
        • GSK Investigational Site
      • Quebec City、Quebec、加拿大、G1V 4M6
        • GSK Investigational Site
      • Québec、Quebec、加拿大、G1V 4G5
        • GSK Investigational Site
      • Trois Rivières、Quebec、加拿大、G8T 7A1
        • GSK Investigational Site
  • 德国
      • Berlin、德国、13086
        • GSK Investigational Site
      • Berlin、德国、10717
        • GSK Investigational Site
      • Berlin、德国、13597
        • GSK Investigational Site
      • Berlin、德国、12203
        • GSK Investigational Site
      • Berlin、德国、12157
        • GSK Investigational Site
      • Hamburg、德国、22299
        • GSK Investigational Site
    • Bayern
      • Gauting、Bayern、德国、82131
        • GSK Investigational Site
      • Muenchen、Bayern、德国、80539
        • GSK Investigational Site
    • Brandenburg
      • Cottbus、Brandenburg、德国、03050
        • GSK Investigational Site
    • Sachsen
      • Leipzig、Sachsen、德国、04357
        • GSK Investigational Site
      • Leipzig、Sachsen、德国、04103
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck、Schleswig-Holstein、德国、23552
        • GSK Investigational Site
      • Schleswig、Schleswig-Holstein、德国、24837
        • GSK Investigational Site
  • 法国
      • Bayonne cedex、法国、64109
        • GSK Investigational Site
      • Dijon Cedex、法国、21033
        • GSK Investigational Site
      • Grenoble cedex 9、法国、38043
        • GSK Investigational Site
      • Lille Cedex、法国、59037
        • GSK Investigational Site
      • Lyon cedex 04、法国、69317
        • GSK Investigational Site
      • Marseille cedex 03、法国、13331
        • GSK Investigational Site
      • Nantes cedex 1、法国、44093
        • GSK Investigational Site
      • Nantes cedex 2、法国、44277
        • GSK Investigational Site
      • Paris Cedex 18、法国、75877
        • GSK Investigational Site
      • Pessac cedex、法国、33604
        • GSK Investigational Site
      • Reims Cedex、法国、51092
        • GSK Investigational Site
      • Rouen Cedex、法国、76031
        • GSK Investigational Site
      • Strasbourg、法国、67091
        • GSK Investigational Site
      • Tarbes cedex 9、法国、65013
        • GSK Investigational Site
      • Villefranche sur Saône、法国、69655
        • GSK Investigational Site
  • 澳大利亚
    • New South Wales
      • Coffs Harbour、New South Wales、澳大利亚、2450
        • GSK Investigational Site
  • 美国
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • GSK Investigational Site
    • California
      • Fresno、California、美国、93720
        • GSK Investigational Site
      • Los Angeles、California、美国、90025
        • GSK Investigational Site
      • Newport Beach、California、美国、92663
        • GSK Investigational Site
      • Riverside、California、美国、92506
        • GSK Investigational Site
      • Rolling Hills Estates、California、美国、90274
        • GSK Investigational Site
      • San Diego、California、美国、92123
        • GSK Investigational Site
      • Upland、California、美国、91786
        • GSK Investigational Site
    • Florida
      • Tallahassee、Florida、美国、32308
        • GSK Investigational Site
    • Kentucky
      • Owensboro、Kentucky、美国、42301
        • GSK Investigational Site
    • Maryland
      • Baltimore、Maryland、美国、21236
        • GSK Investigational Site
      • Columbia、Maryland、美国、21044
        • GSK Investigational Site
    • Minnesota
      • Minneapolis、Minnesota、美国、55402
        • GSK Investigational Site
      • Plymouth、Minnesota、美国、55441
        • GSK Investigational Site
    • New York
      • Corning、New York、美国、14830
        • GSK Investigational Site
    • North Carolina
      • Charlotte、North Carolina、美国、28277
        • GSK Investigational Site
      • Shelby、North Carolina、美国、28150
        • GSK Investigational Site
    • Ohio
      • Cincinnati、Ohio、美国、45231
        • GSK Investigational Site
    • Oregon
      • Medford、Oregon、美国、97504
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15241
        • GSK Investigational Site
    • South Carolina
      • Greenville、South Carolina、美国、29615
        • GSK Investigational Site
  • 英国
      • Birmingham、英国、B15 2WB
        • GSK Investigational Site
      • Birmingham、英国、B18 7QH
        • GSK Investigational Site
      • Cambridge、英国、CB2 2XY
        • GSK Investigational Site
      • Crawley、英国、RH10 7DX
        • GSK Investigational Site
      • Liverpool、英国、L12 2AP
        • GSK Investigational Site
      • London、英国、SW17 0RE
        • GSK Investigational Site
      • Middlesbrough、英国、TS4 3BW
        • GSK Investigational Site
      • Radstock, Bath、英国、BA3 2UH
        • GSK Investigational Site
      • Salford、英国、M6 8HD
        • GSK Investigational Site
      • Trowbridge、英国、BA14 9AR
        • GSK Investigational 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 及以上 (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:

  • At least 12 years of age at study visit.
  • Participants eligible for enrolment and entry into the study must meet the following definition of severe asthma, which is based on the definition of severe asthma described in the European Respiratory Society/ American Thoracic Society (ERS/ATS) Guidelines for severe asthma: Asthma which requires treatment with guideline suggested medications for Global Initiative for Asthma (GINA) steps 4-5 asthma for the previous year (i.e., at least 12 months).

Patients must be treated with high dose ICS PLUS at least one of the following: LABA, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year).

SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the maximum recommended dose of the ICS/LABA combination per local label is acceptable.

  • Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. A parent or legal guardian must provide informed consent for participants less than 18 years of age at study visit (or less than minimum age to be considered an adult per local laws).

Exclusion Criteria:

Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)

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

  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Non-drug interventional group
All enrolled participants will provide a blood sample, spirometry , and feedback on their severe asthma symptoms via questionnaires, and health related quality of life and burden of illness through response to self-administered questionnaires. No investigational product will be administered to participants.
药品：Short Acting Beta Agonist (SABA)
Participants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments

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
Number of severe asthma patients eligible for one or more biologic treatments for asthma
大体时间：Day 1
Biologic treatments for asthma will include mepolizumab (anti-Interleukin [IL] 5), omalizumab (anti-immunoglobulin E [IgE]), and reslizumab (anti-IL5).
Day 1

次要结果测量

结果测量
措施说明
大体时间
Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months
大体时间：Day 1
Day 1
Mean and median Charlson Comorbidity Index score
大体时间：Day 1
The Charlson Comorbidity Index is a score that is based on age and the presence of 19 comorbidities. The mean and median Charlson Comorbidity Index score will be calculated and reported
Day 1
Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio
大体时间：Day 1
Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
Day 1
Mean post-bronchodilator FEV1/FVC ratio
大体时间：Day 1
Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
Day 1
Mean pre-bronchodilator FEV1
大体时间：Day 1
Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
Day 1
Mean post-bronchodilator FEV1
大体时间：Day 1
Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
Day 1
Mean pre-bronchodilator FVC
大体时间：Day 1
Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
Day 1
Mean post-bronchodilator FVC
大体时间：Day 1
Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility
Day 1
Mean and median levels of blood eosinophils
大体时间：Day 1
Day 1
Mean and median levels of total IgE
大体时间：Day 1
Day 1
Mean and median levels of specific IgE
大体时间：Day 1
Day 1
Descriptive statistics for asthma Control Questionnaire (ACQ-5)
大体时间：Day 1
Day 1
Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ)
大体时间：Day 1
Day 1
Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S)
大体时间：Day 1
Day 1
Descriptive statistics for EuroQol 5D (EQ-5D-5L)
大体时间：Day 1
Day 1
Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH)
大体时间：Day 1
Day 1
Descriptive statistics for Asthma Symptom Utility Index (ASUI)
大体时间：Day 1
Day 1

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

GlaxoSmithKline

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

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

2014年12月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2014年10月27日

首先提交符合 QC 标准的

2014年11月13日

首次发布 (估计)

2014年11月18日

研究记录更新

最后更新发布 (估计)

2016年4月4日

上次提交的符合 QC 标准的更新

2016年3月31日

最后验证

2016年3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

  • 201722

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.

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