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临床试验/NCT00999466
NCT00999466已完成2 期

A Double-blind, Placebo-controlled, Randomised, Parallel Group, Phase IIa Study to Investigate the Efficacy, Tolerability and Safety of 8 Doses of AZD8848 Administered Intranasally Once Weekly in Mild to Moderate Allergic Asthma Subjects Challenged With an Inhaled Allergen.

AstraZeneca1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年10月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
AstraZeneca
入组人数
60
试验地点
1
主要终点
FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •FEV1 > 70 % of predicted normal pre-bronchodilator
  • •Documented history of asthma
  • •Presence of allergic sensitivity

排除标准

  • •Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
  • •Symptomatic allergic rhinitis
  • •Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study

研究组 & 干预措施

1

Experimental

AZD8848 (30 μg PILOT part and 60 μg MAIN part)

干预措施: AZD8848 (Drug)

2

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose

时间窗: 1 week after last dose

FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose

时间窗: 4 weeks after last dose

FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

FEV1, Late Asthmatic Response (LAR) - Pre-treatment

时间窗: Pre-treatment (Baseline measurement)

Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.

次要结局

  • Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • FEV1, Early Asthmatic Response (EAR) - Pre-treatment(Pre-treatment (Baseline measurement))
  • PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose(1 week after last dose)
  • FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose(4 weeks after last dose)
  • Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge(Pre-treatment, post allergen challenge)
  • Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge(4 weeks after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge(Pre-treatment, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)
  • Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge(1 week after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge(4 weeks after last dose, post allergen challenge)
  • Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge(1 week after last dose, pre allergen challenge)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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