Generation and Cognitive Testing of Informative and Suitable Items for a COPD Exacerbation Recognition Tool (CERT) for Detection of Exacerbations of COPD in Japanese Patients

GlaxoSmithKline K.K.0 个研究点目标入组 150 人开始时间: 2019年1月17日最近更新: 2023年10月17日

适应症

试验速览

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•Patients having COPD attending the outpatient respiratory specialist sites for their disease will be informed about the study and will be invited to join the trial. To be eligible for inclusion, each subject must fulfil ALL of the following criteria:
•1. Male or female of age over 40 years
•2. Spirometrically confirmed COPD or ACOS according to diagnostic criteria in GOLD document
•3. Smoking history (over 10 pack-years)
•4. A treated exacerbation of COPD within 12 months prior to the study visit
•5. Willing and able to provide informed consent, and able to participate focus groups or cognitive interviews. (Translation will be provided for illiterate participants to provide informed consent)

•All patients meeting ANY of the exclusion criteria will be excluded.
•1. Current diagnosis of asthma or clinically relevant bronchiectasis. Note: patients with Asthma COPD Overlap Syndrome (ACOS) ARE eligible
•2. Patients with a concurrent significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases, psychiatric condition, cognitive impairment or any other reasons that in the investigators opinion, would place patients at risk or interfere with study evaluation or affect participation in the study

发起方

GlaxoSmithKline K.K.