Observational study of cough severity in patients with idiopathic pulmonary fibrosis cough
| ISRCTN | ISRCTN57234685 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57234685 |
| IRAS number | 293624 |
| Secondary identifying numbers | IPF-Obs-01, IRAS 293624 |
- Submission date
- 26/04/2021
- Registration date
- 27/04/2021
- Last edited
- 17/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
The aim of this 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.
Who can participate?
Patients aged 40 and over who have a troublesome cough due to IPF
What does the study involve?
Participants will be asked to complete a cough diary containing this questionnaire every evening for two separate 1-week periods with a 1-week gap between these two periods. The cough diary will be completed using 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, participants 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 participants will still be able to participate in the study even if they do not wish to have an interview.
What are the possible benefits and risks of participating?
There will be no direct benefit to participants. However, the results may help the development of future treatments for chronic cough due to IPF.
Where is the study run from?
NeRRe Therapeutics (UK)
When is the study starting and how long is it expected to run for?
December 2020 to July 2021
Who is funding the study?
NeRRe Therapeutics (UK)
Who is the main contact?
Susan Seymore
susan.seymore@nerretherapeutics.com
Contact information
Public
Stevenage Bioscience Catalyst
Gunnells Wood Road
Stevenage
SG1 2FX
United Kingdom
| Phone | +44 (0)7741 634591 |
|---|---|
| susan.seymore@nerretherapeutics.com |
Scientific
Stevenage Bioscience Catalyst
Gunnells Wood Road
Stevenage
SG1 2FX
United Kingdom
| Phone | +44 (0)7827 460726 |
|---|---|
| steve.pawsey@nerretherapeutics.com |
Study information
| Study design | Multi-centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | An observational study to record cough symptom severity in patients with chronic cough due to idiopathic pulmonary fibrosis |
| Study hypothesis | 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). |
| Ethics approval(s) | Approved 22/02/2021, West of Scotland REC 3 (Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0211; WoSREC3@ggc.scot.nhs.uk), REC ref: 21/WS/0014 |
| Condition | Chronic cough due to idiopathic pulmonary fibrosis |
| Intervention | 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 completion, participants will complete two assessments: the Cough Severity numerical rating scale (NRS) and the cough severity visual analogue scale (VAS). On the seventh day of diary completion, participants will complete two assessments: the Cough Severity NRS and the global rating of severity (GRS). On the last day of diary completion, participants will complete all three assessments: the Cough Severity NRS, the cough severity VAS and the GRS. On all other diary completion days, participants will just complete the Cough Severity NRS. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 29/12/2020 |
| Overall study end date | 22/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 28 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 08/04/2021 |
| Recruitment end date | 30/06/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Great Maze Pond
London
SE1 9RT
United Kingdom
Broughton
DN20 0HR
United Kingdom
Sponsor information
Industry
Stevenage Bioscience Catalyst
Gunnells Wood Road
Stevenage
SG1 2FX
United Kingdom
| Phone | +44 (0)1438906960 |
|---|---|
| info@nerretherapeutics.com | |
| Website | http://nerretherapeutics.com/ |
"ROR" |
https://ror.org/04kyz2p97 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from info@nerretherapeutics.com to academic researchers who have a bona fide reason to request them. Only aggregated data will be provided as participants did not give consent for subject level data to be provided to parties other than NeRRe. Requests for data should include a summary of the research project including its objectives, the funding source, the role of the study data in achieving these objectives, the proposed analysis methods and publication plans. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 17/08/2022 | 17/08/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
17/08/2022: A basic results summary has been uploaded.
19/07/2022: The intention to publish date was changed from 31/07/2022 to 31/07/2023.
28/07/2021: IPD sharing statement added.
06/07/2021: The following changes were made to the trial record:
1. Total final enrolment added.
2. The overall trial end date was changed from 31/07/2021 to 22/07/2021.
26/04/2021: Trial's existence confirmed by West of Scotland REC 3.
