Observational Study of Cough Severity in Patients with IPF Cough
Research type
Research Study
Full title
An Observational Study to Record Cough Symptom Severity in Patients with Chronic Cough due to Idiopathic Pulmonary Fibrosis
IRAS ID
293624
Contact name
Susan Seymore
Contact email
Sponsor organisation
NeRRe Therapeutics Ltd
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
Research Summary
The objective of this observational study is to evaluate a new patient questionnaire that measures the severity of cough in patients with idiopathic pulmonary fibrosis (IPF). Cough is a common symptom in patients with IPF and is frequently cited as one of the most burdensome aspects of this terminal disease. NeRRe Therapeutics (which is funding the research) is developing a potential treatment for chronic cough in IPF and plans to use this cough questionnaire in clinical trials to see whether the treatment is effective. However, before the questionnaire can be used in trials testing this potential treatment, information needs to be gathered on the questionnaire itself.
Patients that have a troublesome cough due to IPF will be recruited at 1 site in the UK. They will be asked to complete a cough diary containing this questionnaire every evening for 2 separate 1-week periods, with a 1-week gap between these 2 periods. The cough diary will be completed using a mobile application (an app) on a phone or tablet. The cough diary app has been designed to be very simple to use and should take no more than a minute each day. At the end of the diary completion period, subjects will be invited to have a telephone interview with a trained researcher, to find out more about their cough and to gather feedback on the cough diary. This interview will be optional, and subjects will still be able to participate in the study even if they do not wish to have an interview.
There will be no direct benefit to patients participating in this study. However, the results may help the development of future treatments for chronic cough due to IPF.Summary of Results
A total of 28 participants with chronic cough associated with the lung scarring disease idiopathic pulmonary fibrosis (IPF) took part in the study. Twenty seven completed the daily diary and 21 underwent an interview at the end of the diary completion period. Participants had an average age of 72 years and most (20 of 28) were male. Around half were taking one of the two approved disease modifying therapies (nintedanib and pirfenidone).The study was undertaken to assess a new cough severity scoring scale in patients with IPF, and in particular to see how the scores varied between participants and from day to day and week to week. It was found that the scores were very consistent and averaged around 5 (out of 10) on each day and during both weeks of the diary completion period. The range of weekly average scores in individual participants was from 0 to 8. Only one participant scored their cough as 0 and two scored it and 10 on single occasions, indicating that the assessment did not have significant ‘floor’ or ‘ceiling’ effects.
When asked to rate their cough using a verbal rating scale, the most common category was moderate severity (10 participants in week 1 and 15 in week 2). The majority of subjects (17 of 22 gave the same rating in both weeks, with a difference of only one category in those subjects who gave different ratings.
The numerical cough rating scores in the daily diary correlated well with the verbal rating scale descriptions. A moderate cough was typically associated with a mean daily diary score of 5.
In the interviews conducted after the study, it was found that almost all the participants found the daily diary question intuitive to understand and the technology (an App on a smartphone) was easy enough to use. Many participants also reported experiencing two distinct types of cough, one of which only occurred for a few minutes on waking or rising in the morning. This was different in nature to the cough they experienced during the rest of the day. This description of the different cough types will be an important consideration for future cough assessment questions.REC name
West of Scotland REC 3
REC reference
21/WS/0014
Date of REC Opinion
22 Feb 2021
REC opinion
Further Information Favourable Opinion