Sensations and triggers of coughing pre- and post-treatment in chronic cough
| ISRCTN | ISRCTN13970657 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13970657 |
| IRAS number | 288299 |
| Secondary identifying numbers | IRAS 288299, CPMS 54114 |
- Submission date
- 14/09/2022
- Registration date
- 26/09/2022
- Last edited
- 16/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
The researchers want to look at a new questionnaire for patients with a chronic cough - the TOPIC questionnaire. It is hoped that this questionnaire describes some of the typical symptoms patients experience. The researchers want to see if this questionnaire changes with the treatment of chronic cough in clinic. They want to see if the changes relate to other measures, such as cough scores and number of coughs over 24 hours.
Who can participate?
Patients over the age of 18 years with a chronic cough (over 8 weeks) attending a specialist cough clinic in Manchester
What does the study involve?
Some particular medications (any that cause cough) may need to be reviewed. Patients will then complete questionnaires and wear a cough recorder for 24 hours. Treatment will then be given according to the normal approach in the clinic. Once the cough has improved/stabilised the questionnaires and cough recording will be repeated.
What are the possible benefits and risks of participating?
The benefits include furthering our understanding of chronic cough as a condition. There are no risks.
Where is the study run from?
Manchester University NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2019 to September 2025
Who is funding the study?
Merck Sharp & Dohme (UK)
Who is the main contact?
1. Dr Paul Marsden, cough.research@manchester.ac.uk
2. Cough Research Team General, cough.research@mft.nhs.uk
Contact information
Principal Investigator
Wythenshawe Hospital and Manchester University
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)1612915921 |
|---|---|
| cough.research@manchester.ac.uk |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 42381_PIS_V2_29Jul22.pdf |
| Scientific title | Sensations and Triggers of Coughing pre- and post-treatment in Chronic Cough (STaRR) |
| Study acronym | STaRR |
| Study hypothesis | It is hypothesized that the sensations associated with chronic cough as captured by the ToPiC questionnaire change following standard treatment for chronic cough. It is also hypothesized that these changes correlate with both objective/subjective measures of cough and cough-specific quality of life and that the ToPiC questionnaire will be able to differentiate between those with refractory chronic cough (RCC) or unexplained chronic cough (UCC) and non-RCC/UCC. |
| Ethics approval(s) | Approved 22/08/2022, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8143; gmsouth.rec@hra.nhs.uk), ref: 22/NW/0210 |
| Condition | Refractory and unexplained chronic cough |
| Intervention | Subjects will be recruited from the specialist Cough Clinic and undergo the following procedures: Baseline: 1. Cough visual analogue scale (VAS) 2. Numerical (Likert) cough severity score 3. Cough-related quality of life questionnaire (Leicester Cough Questionnaire [LCQ]) 4. 24-hour cough monitoring (VitaloJAK) Subjects will then undergo investigation and treatment according to the North West Cough Network guidelines which have been developed locally and based upon published guidelines and evidence. Once the end of the algorithm has been reached and/or the cough has reached stability, patients will undergo identical procedures as at baseline. |
| Intervention type | Other |
| Primary outcome measure | Characteristics and severity of cough measured using the ToPiC questionnaire score before treatment (Day 1) and after completion of investigation and treatment (3-6 months) after enrolment |
| Secondary outcome measures | Measured before treatment (Day 1) and after completion of investigation and treatment (3-6 months) after enrolment: 1. 24-hour cough frequency measured using VitaloJAK 2. Cough-related quality of life measured using the Leicester Cough Questionnaire [LCQ]) 3. Patient-reported cough severity measured using cough visual analogue scale (VAS) |
| Overall study start date | 01/01/2019 |
| Overall study end date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 105 |
| Participant inclusion criteria | 1. Adults over the age of 18 years 2. Referred to the tertiary chronic cough clinic 3. Non-smokers or ex-smokers <20 pack years and greater than 6 months of abstinence 4. Persistent cough of at least 8 weeks duration |
| Participant exclusion criteria | 1. Currently taking angiotensin-converting enzyme (ACE) inhibitors 2. Recent history of upper or lower respiratory tract infection or significant change of pulmonary status within 4 weeks of enrolment 3. Current smoker or smoking history >20 pack years |
| Recruitment start date | 01/09/2022 |
| Recruitment end date | 30/08/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Wythenshawe
Manchester
M23 9LT
United Kingdom
Nell Lane
Manchester
M20 2LR
United Kingdom
Altrincham
WA14 2RE
United Kingdom
North Shields
NE29 8NH
United Kingdom
Fulwood
Preston
PR2 9HT
United Kingdom
Sponsor information
Hospital/treatment centre
R&I Department
Research Office
1st Floor
Nowgen Centre
29 Grafton Street
Manchester
M23 9LT
England
United Kingdom
| Phone | +44 (0)161 276 4125 |
|---|---|
| research.sponsor@mft.nhs.uk | |
| Website | https://mft.nhs.uk/wythenshawe/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- MSD United Kingdom, Merck Sharp & Dohme, Merck Sharp & Dohme Corp., MSD
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | National and international conferences, medical journal, PhD thesis |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 29/07/2022 | 16/09/2022 | No | Yes |
| Protocol file | version 2 | 29/07/2022 | 16/09/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 5.0 | 27/09/2023 | 16/04/2025 | No | Yes |
| Protocol file | version 4.0 | 27/09/2023 | 16/04/2025 | No | No |
Additional files
Editorial Notes
16/04/2025: Protocol version 4.0 (not peer reviewed) and participant information sheet version 5.0 uploaded.
14/04/2025: The following changes were made:
1. The overall study end date was changed from 30/08/2025 to 30/09/2025.
2. The target number of participants was changed from 150 to 100.
3. The study participating centres North Tyneside General Hospital and Royal Preston Hospital, were added.
13/09/2024: The following changes were made:
1. The recruitment end date was changed from 01/09/2024 to 30/08/2024.
2. The overall study end date was changed from 01/01/2025 to 30/08/2025.
3. The intention to publish date was changed from 01/09/2025 to 30/12/2025.
4. The total final enrolment number was added.
03/10/2022: Internal review.
16/09/2022: Trial's existence confirmed by North West - Greater Manchester South Research Ethics Committee.
