Observational study of cough severity in patients with idiopathic pulmonary fibrosis cough

Not Applicable

Completed

• Conditions: Chronic cough due to idiopathic pulmonary fibrosis; Respiratory; Other interstitial pulmonary diseases with fibrosis

• Registration Number: ISRCTN57234685
• Lead Sponsor: eRRe Therapeutics (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-27
• Study Completion: 2021-07-22
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified