Chronic cough due to idiopathic pulmonary fibrosis Respiratory Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Participants will be asked to record measures of coughing severity in a diary app once a day for two separate 7 day periods with approximately 1 week between the two periods. On the first day of diary
Sponsors
NeRRe Therapeutics (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough severity on a 0-10 scale (where 0 is “no coughing” and 10 is “coughing as bad as you can imagine”) using the cough severity numerical rating scale (NRS) on Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cough severity (none, mild, moderate or severe) measured using the Global Rating Scale (GRS) on Days 7 and 14 2. Cough severity (between 0 and 100 mm, where 0 is “no coughing” and 10 is “coughing as bad as you can imagine”), measured using the cough severity visual analogue scale (VAS) on Days 1 and 14 3. Patients’ experience of chronic cough due to IPF collected by interview between Day 14 and 42 | — |
Countries
England, United Kingdom
Contacts
Public ContactSusan Seymore
Outcome results
None listed