The cystic fibrosis home sputum induction trial
| ISRCTN | ISRCTN86523335 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86523335 |
| IRAS number | 281516 |
| Secondary identifying numbers | 19/NOV/7783, CPMS 54158, IRAS 281516 |
- Submission date
- 07/10/2022
- Registration date
- 24/10/2022
- Last edited
- 01/11/2022
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Early infection in children with cystic fibrosis (CF) needs to be treated in order to prevent lung disease. Sampling the lower airway for bacterial pathogens can be difficult in children with CF who are often unable to cough up secretions even if they are unwell and have a wet cough. The CF-SpIT trial showed that the sputum induction procedure is a simple effective approach to sampling lower airway secretions in children, and is as effective as bronchoscopy and bronchoalveolar lavage in children who are unwell. The sputum induction procedure involves taking a saltwater nebuliser and having chest physiotherapy. This loosens secretions which can then be coughed up. One important consideration in introducing routine sputum induction is that it is currently performed by a health professional and takes approximately 30 minutes to perform. Staff resources are therefore a limiting factor to the universal application of the sputum-induction procedure. The current trial aims to look at whether this procedure and others can be performed equally well at home by children and their parents.
Who can participate?
Children aged between 6-18 years old from the South Wales Cystic Fibrosis Network
What does the study involve?
The Cystic Fibrosis Home Sputum-induction trial (CF HomeSpIT) will compare the microbiology yield from saliva and sputum-induction performed at home by patients and their parents, with cough swab, saliva and sputum-induction performed in the clinic. This will test whether home sampling may be used as a valuable addition to standard care in children with CF. CF-HomeSpIT also looks at microbiota in these samples, helping to understand the relationship between good and bad bacteria in these samples, and which samples are best for this scientific approach.
What are the possible benefits and risks of participating?
Any additional pathogens identified from the extra tests will be used immediately in the clinical management of the patient. There are no potentially common or serious risks to participating.
Where is the study run from?
The Children's Hospital for Wales, Heath Park, Cardiff (UK)
When is the study starting and how long is it expected to run for?
June 2022 to January 2026
Who is funding the study?
1. Cystic Fibrosis Foundation (UK)
2. Cardiff and Vale University Health Board (UK)
3. Children's Hospital for Wales (UK)
Who is the main contact?
Dr Julian Forton (UK)
julian.forton@wales.nhs.uk
Contact information
Principal Investigator
The Children's Hospital for Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom
 ORCID ID |
0000-0002-0580-0432 |
|---|---|
| Phone | +44(0)2920 744891 |
| julian.forton@wales.nhs.uk |
Study information
| Study design | Prospective internal-control unblinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 42559_CF-HOMESPIT_PIS_Parents_v1.1_26july2022.pdf |
| Scientific title | The cystic fibrosis home sputum induction trial - self-management for better microbiology surveillance |
| Study acronym | CF-HomeSpIT |
| Study hypothesis | To compare pathogen yield from home sputum induction and saliva with clinic sputum induction, saliva and cough swab in children with cystic fibrosis |
| Ethics approval(s) | Approved 25/07/2022, Research Ethics Service Health and Care Research Wales (Public Health Wales Meeting Room, Building 1, St. David’s Park, Carmarthen SA31 3HB, Wales, UK; +44 (0)2920 230457, (0)7920 565664; Wales.REC7@wales.nhs.uk), ref: 22/WA/0196 |
| Condition | Cystic fibrosis |
| Intervention | Home sputum induction, home saliva and clinic saliva sampling for comparative microbiology analysis and scientific microbiota analysis compared to clinic gold standard cough swab and sputum induction. There was no follow-up activity but all microbiology results will be used in the immediate clinical management of patients. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pathogen detection rate of matched home sputum induction and home saliva versus Gold standard clinic cough swab measured using microbiology analysis as per CF Trust Microbiology Guidelines at a single time point |
| Secondary outcome measures | Pathogen detection rate of home sputum induction and home saliva versus clinic sputum induction and saliva samples measured using microbiology analysis as per CF Trust Microbiology Guidelines at a single time point |
| Overall study start date | 01/06/2022 |
| Overall study end date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Cystic fibrosis 2. Using hypertonic saline as part of an established physiotherapy regimen at home |
| Participant exclusion criteria | Unable to expectorate spontaneously |
| Recruitment start date | 09/09/2022 |
| Recruitment end date | 09/09/2025 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff
CF14 4XW
Cardiff
CF14 4XW
United Kingdom
Sponsor information
Hospital/treatment centre
Heath Park
Cardiff
CF14 4XW
Wales
United Kingdom
| Phone | +44(0)2921846126 |
|---|---|
| research.governance@wales.nhs.uk | |
| Website | http://www.cardiffandvaleuhb.wales.nhs.uk/home |
"ROR" |
https://ror.org/0489f6q08 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CF Foundation, CFF
- Location
- United States of America
No information available
No information available
Results and Publications
| Intention to publish date | 01/03/2026 |
|---|---|
| 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 | Planned publication in a high impact peer-reviewed journal |
| 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 1.1 | 26/07/2022 | 10/10/2022 | No | Yes |
| Protocol file | version 1.1 | 26/07/2022 | 10/10/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
01/11/2022: The sponsor email was changed.
