The effect on blood and sputum measures of a new drug used to treat cystic fibrosis patients
| ISRCTN | ISRCTN72529591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72529591 |
| Secondary identifying numbers | ManARTS application M2020-100 |
- Submission date
- 18/02/2022
- Registration date
- 02/03/2022
- Last edited
- 29/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Cystic fibrosis patients have donated sputum and blood samples to be stored in the ManARTS biobank, which is a repository of detailed clinical information and of biological samples. These samples were taken before and after commencing a new highly effective medication called Kaftrio. We will examine these samples for changes in the protein make-up related to starting this medication. This will give us a better understanding of how Kaftrio works and if any proteins might have potential as a new test to improve treatment.
Cystic fibrosis is an inherited condition that causes sticky mucus to build up in the lungs and digestive system. This causes lung infections and problems with digesting food.
Who can participate?
The study will be conducted with patients from the Manchester Adult Cystic Fibrosis Centre.
What does the study involve?
Samples will be examined for changes in the protein make-up related to starting Kaftrio.
What are the possible benefits and risks of participating?
The benefits of taking part mainly relate to developing new tests that might eventually improve clinical care. We anticipate no disadvantages.
Where is the study run from?
Manchester Adult Cystic Fibrosis Centre (UK)
When is the study starting and how long is it expected to run for?
August 2020 to June 2023
Who is funding the study?
North West Lung Centre charity (UK)
Who is the main contact?
Dr Robert Lord, robert.lord@mft.nhs.uk
Contact information
Principal Investigator
Wythenshawe Hospital
Manchester University NHS Foundation Trust
Southmoor Road
Manchester
M21 9AX
United Kingdom
 ORCID ID |
0000-0001-9008-2502 |
|---|---|
| Phone | +44 1612913518 |
| robert.lord@mft.nhs.uk |
Study information
| Study design | Single-centre longitudinal observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not applicable (study uses existing data) |
| Scientific title | The changes in sputum and plasma proteome in response to CFTR therapy |
| Study acronym | SPRINT |
| Study objectives | Cystic fibrosis has a distinct plasma and sputum proteome that relates to severity of lung disease and is modifiable by therapies. |
| Ethics approval(s) | No approval needed, samples collected in biobank |
| Health condition(s) or problem(s) studied | Cystic fibrosis |
| Intervention | We are using sputum and blood samples provided to a research biobank by cystic fibrosis patients commencing the drug Kaftrio. All patients have provided consent. These samples will be analysed by mass spectrometry to assess large-scale changes in protein abundance (proteome) before and after therapy |
| Intervention type | Other |
| Primary outcome measure | Longitudinal change in sputum and plasma proteome associated with therapy (univariate and multivariate analyses). The proteome will be measured using mass spectrometry. |
| Secondary outcome measures | Comparison of proteome change and clinical response to therapy measured using biobank samples and patient records at a single time point |
| Overall study start date | 01/08/2020 |
| Completion date | 01/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 97 |
| Key inclusion criteria | Cystic fibrosis patients commenced on the CFTR modulator Kaftrio |
| Key exclusion criteria | Any factor that would be expected to significantly influence the proteome in its own right, including conditions requiring immunosuppressive medication and immunodeficiency syndromes. |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 01/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sponsor information
Hospital/treatment centre
Cobbett House
Oxford Road
Manchester
M13 9WL
England
United Kingdom
| Phone | +44 161 2761234 |
|---|---|
| research.sponsor@mft.nhs.uk | |
| Website | https://mft.nhs.uk/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Publications and relevant conferences |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository |
Editorial Notes
29/04/2024: The intention to publish date was changed from 01/10/2023 to 01/08/2024.
06/03/2023: IPD sharing statement added.
20/02/2023: The overall trial end date was changed from 01/01/2023 to 01/06/2023.
28/09/2022: The total final enrolment was added.
02/03/2022: Trial's existence confirmed by Manchester University NHS Foundation Trust.
