An observational study to record cough symptom severity in patients with chronic cough due to idiopathic pulmonary fibrosis

eRRe Therapeutics (United Kingdom)0 个研究点目标入组 28 人开始时间: 2021年4月27日最近更新: 2022年8月29日

试验速览

暂无简介。

•1. Male or female, aged =40 years of age
•2. Able to understand and comply with the requirements of the study and sign Informed consent forms
•3. Good understanding of written and spoken English
•4. Diagnosis of IPF established according to the 2018 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline
•5. Life expectancy of at least 6 months
•6. Cough that is attributed to IPF and which has been present for at least 8 weeks
•7. Cough severity rated at least 4 on the Cough Severity NRS at screening (verbal assessment acceptable for screening)
•8. If taking pirfenidone or nintedanib, the dose should have been stable for at least 1 month prior to screening

•1. Recent respiratory tract infection (<4 weeks prior to Screening)
•2. Recent acute exacerbation of IPF (<8 weeks prior to Screening)
•3. Current smokers or ex-smokers with <6 months’ abstinence prior to Screening
•4. Any clinically significant or unstable medical or psychiatric condition that would, in the opinion of the investigator, interfere with the subject's ability to participate in the study safely
•5. Participation in any clinical research study evaluating an investigational drug or therapy within 30 days or within 5 half-lives (whichever is longer) of the investigational drug prior to Screening. If the subject was in an observational clinical study no washout is required
•6. Subjects who, in the opinion of the Investigator, should not participate in the study for any other reason

发起方

eRRe Therapeutics (United Kingdom)