Delving into the Latest Updates on Astrazeneca Dunkerque Production SCS with Synapse

Overview

Tags

Immune System Diseases

Respiratory Diseases

Infectious Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

GR x mAChRs x β2-adrenergic receptor	1

本研究的主要目的是研究布地奈德、格隆溴铵和富马酸福莫特罗（BGF）定量吸入器（MDI）与安慰剂MDI相比以及BGF MDI与布地奈德和富马酸福莫特罗（BFF）MDI相比对等时IC的影响。布地奈德、格隆溴铵和富马酸福莫特罗MDI可减少动态过度充气并提高IC，从而改善COPD参与者的运动耐量。本研究的次要目的是研究BGF MDI与安慰剂MDI相比以及随后的BFF MDI对运动耐受时间的影响。通过恒定功率测试（CWT）评估的运动耐受时间被认为是对COPD治疗干预应答的一项有价值的评估。

[Translation]

The primary objective of this study was to investigate the effects of budesonide, glycopyrrolate, and formoterol fumarate (BGF) metered dose inhaler (MDI) compared with placebo MDI and BGF MDI compared with budesonide and formoterol fumarate (BFF) MDI on isochronic IC. Budesonide, glycopyrrolate, and formoterol fumarate MDI may reduce dynamic hyperinflation and increase IC, thereby improving exercise tolerance in COPD participants. The secondary objective of this study was to investigate the effects of BGF MDI compared with placebo MDI and subsequently BFF MDI on exercise tolerance time. Exercise tolerance time, assessed by constant power test (CWT), is considered a valuable assessment of response to therapeutic interventions in COPD.

Start Date18 Oct 2024

Sponsor / Collaborator

AstraZeneca AB

[+2]

CTR20242750

/ RecruitingPhase 3

一项随机、双盲、平行分组、多中心、III期研究，评估布地奈德、格隆溴铵和富马酸福莫特罗定量吸入器与格隆溴铵和富马酸福莫特罗MDI相比在慢性阻塞性肺疾病心肺结局方面的有效性（THARROS）

[Translation] A randomized, double-blind, parallel-group, multicenter, phase III study to evaluate the effectiveness of budesonide, glycopyrrolate, and formoterol fumarate metered-dose inhaler compared with glycopyrrolate and formoterol fumarate MDI on cardiopulmonary outcomes in chronic obstructive pulmonary disease (THARROS)

主要目的：在未接受ICS的COPD人群中，评价三联治疗（BGF MDI 320/14.4/9.6 μg）与支气管扩张剂二联治疗（GFF MDI 14.4/9.6 μg）相比对重度心肺结局的作用。次要目的：在未接受ICS的COPD人群中，评价三联治疗（BGF MDI 320/14.4/9.6 μg）与支气管扩张剂二联治疗（GFF MDI 14.4/9.6 μg）相比，对：1. 重度COPD急性加重的作用。2.重度心脏事件的作用。3.心肺源性死亡的作用。4.中度/重度COPD急性加重的作用。5.至MI导致住院（或心源性死亡）的时间的作用。6.至HF导致的急诊就诊/住院（或心源性死亡）的时间的作用。探索性目的：在未接受ICS的COPD人群中，评价三联治疗（BGF MDI 320/14.4/9.6 μg）与二联支气管扩张剂治疗（GFF MDI 14.4/9.6 μg）相比，对：1. 全因死亡的作用。2.CV事件的作用。3.计划外医疗卫生资源使用的影响。安全性目的：评估BGF MDI和GFF MDI的安全性和耐受性

[Translation]

Primary objective: To evaluate the effect of triple therapy (BGF MDI 320/14.4/9.6 μg) compared with bronchodilator dual therapy (GFF MDI 14.4/9.6 μg) on severe cardiopulmonary outcomes in COPD population not receiving ICS. Secondary objectives: To evaluate the effect of triple therapy (BGF MDI 320/14.4/9.6 μg) compared with bronchodilator dual therapy (GFF MDI 14.4/9.6 μg) on: 1. Severe COPD exacerbations. 2. Severe cardiac events. 3. Cardiopulmonary death. 4. Moderate/severe COPD exacerbations. 5. Time to hospitalization (or cardiac death) for MI. 6. Time to emergency department visit/hospitalization (or cardiac death) for HF in COPD population not receiving ICS. Exploratory objective: To evaluate the effect of triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on: 1. All-cause mortality. 2. Effect on CV events. 3. Effect on unplanned use of health care resources. Safety objective: To evaluate the safety and tolerability of BGF MDI and GFF MDI

Start Date30 Aug 2024

Sponsor / Collaborator

AstraZeneca AB

[+2]

CTR20242470

/ CompletedPhase 1

一项开放性、单次给药、单臂、I期研究，评价PT027递送的布地奈德和沙丁胺醇在中国健康受试者中的药代动力学、安全性和耐受性

[Translation] An open-label, single-dose, single-arm, Phase I study evaluating the pharmacokinetics, safety, and tolerability of budesonide and salbutamol delivered by PT027 in healthy Chinese subjects

主要目的：研究BDA MDI单次给药递送的布地奈德和沙丁胺醇在中国健康受试者中的PK特征次要目的：评估BDA MDI单次给药递送的布地奈德和沙丁胺醇在中国健康受试者中的安全性和耐受性

[Translation]

Primary objective: To investigate the PK characteristics of budesonide and salbutamol delivered by a single dose of BDA MDI in healthy Chinese subjects Secondary objective: To evaluate the safety and tolerability of budesonide and salbutamol delivered by a single dose of BDA MDI in healthy Chinese subjects

Start Date19 Aug 2024

Sponsor / Collaborator

AstraZeneca Global R&D (China) Co., Ltd.

[+2]

100 Clinical Results associated with Astrazeneca Dunkerque Production SCS

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0 Patents (Medical) associated with Astrazeneca Dunkerque Production SCS

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100 Deals associated with Astrazeneca Dunkerque Production SCS

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100 Translational Medicine associated with Astrazeneca Dunkerque Production SCS

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Pipeline

Pipeline Snapshot as of 01 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3 Clinical

1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Budesonide/Formoterol fumarate/Glycopyrronium Bromide ( GR x mAChRs x β2-adrenergic receptor )	Moderate chronic obstructive pulmonary disease More	Phase 3