A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - CRESCENDO

AstraZeneca AB0 个研究点目标入组 288 人2022年10月26日

概览

暂无简介。

注册库

who.int

开始日期

2022年10月26日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\. Confirmed primary diagnosis of moderate to severe COPD as per FEV1/FVC \< 0\.7, and post\-BD FEV1 \= 25% predicted)
•2\. Current or ex\-smokers with a tobacco history of \= 10 pack\-years
•3\. High risk of exacerbations as defined by any one of the following:
•(a) A documented history of \= 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days’ duration (or 1 injection of Depot formulation), or hospitalisation for reason of AECOPD in the 24 months prior to screening or
•(b) Frequent productive cough, defined as a positive response to both of the following questions:
•Over the past 3 months, I have coughed at least several days a week
•Over the past 3 months, I have brought up phlegm (sputum) at least several days a week, or
•(c) Post\-BD FEV1 \< 50% predicted.
•4\. Clinically stable and free from an exacerbation of COPD for 1 month prior to SV1 (screening) and prior to Day 1\.
•5\. Participants who are at least 70% compliant with each of the following: morning e\-Diary, evening e\-Diary, and PEF measurements during the 14 days preceding SV3 based on the e\-Diary.

•1\. Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years
•2\. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin and stable prostate cancer)
•3\. Evidence of untreated active TB:
•Participants currently receiving treatment for active TB may be considered after completion of an appropriate course of therapy.
•4\. Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow\-up.
•5\. Current diagnosis of hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH \= 10 mIU/mL), or any clinically significant thyroid disease.
•6\. Participant who is going to start or finish intensive COPD rehabilitation program at anytime during study period. Participants can be recruited immediately following the completion of their COPD rehabilitation program.