Cystic Fibrosis (CF)SPICE-CFNCT07879651
SPutum Induction and Nebuliser deviCEs for Patients With CF
A study testing Sputum induction in people with Cystic Fibrosis (CF) and Cystic Fibrosis Lung Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of the SPICE-CF feasibility trial is to learn whether it is feasible to recruit and retain people with cystic fibrosis (CF) who are unable to produce sputum spontaneously in a study comparing two different nebuliser devices for sputum induction. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis (CF), Cystic Fibrosis Lung Disease
- What is being tested?
- Sputum induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of CF (confirmed by standard criteria)
- Sixteen years of age or over
Who cannot join
- History of intolerance to hypertonic saline 3% or 7%
- Lung function impairment (<30%pp FEV1)
- Hypoxia (oxygen saturations of less than 90% on room air)
- Any haemoptysis within past 2 weeks
- Pneumothorax within 6 weeks
- Unstable cardiovascular status as determined by clinical assessment
Show all 18Show fewer
- Any known history or known family history of thoracic or cerebral aneurysm
- Acute pulmonary emboli (within 6 weeks)
- Acute undifferentiated chest pain
- Fractured ribs or other chest trauma in the past 6 weeks
- Recent eye surgery within past 6 weeks
- Inability to perform spirometry
- Treatment for a pulmonary exacerbation within 21 days of screening visit
- Inability to give consent
- Current participation in another interventional medicinal study
- Spontaneous sputum production
- Inability/unwillingness to expectorate
- Pregnancy or currently trying to conceive
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Royal Brompton Hospital
London, SW3 6NP
Gemma Stanford, BSc (Hons), PhD, 07824636504, gemma.stanford2@nhs.net
Afrasiab Ahmad, BSc (Hons), afrasiab.ahmad2@nhs.net
About this study
Official title: SPICE-CF: Sputum Induction and Nebuliser Devices for Patients With Cystic Fibrosis - a Feasibility Trial
The goal of the SPICE-CF feasibility trial is to learn whether it is feasible to recruit and retain people with cystic fibrosis (CF) who are unable to produce sputum spontaneously in a study comparing two different nebuliser devices for sputum induction. The study will also assess how acceptable and practical the sputum induction procedures are.
The main questions it aims to answer are:
Read more
- Is it feasible to recruit and retain people with cystic fibrosis in a study comparing two nebuliser devices for sputum induction?
- Can sputum be successfully obtained using each nebuliser device?
- How acceptable are the two nebuliser devices to participants?
- How long does sputum induction take with each device?
- What microorganisms are identified in sputum collected using each device?
- Can a visual scoring system be used to distinguish sputum from saliva and describe sputum characteristics?
Researchers will compare a jet nebuliser with an E-flow Rapid nebuliser. Each participant will undergo sputum induction using both devices, with the order in which the devices are used determined at random.
Participants will:
- Attend two study visits, separated by at least 2 weeks
- Receive a bronchodilator before sputum induction
- Inhale hypertonic saline using either the jet nebuliser or E-flow Rapid nebuliser
- Perform their usual airway clearance technique with supervision from a physiotherapist
- Have their lung function, oxygen levels, heart rate, and chest sounds monitored
- Provide sputum produced during the procedure for assessment and routine microbiological testing
- Complete a brief questionnaire about their experience and the acceptability of each nebuliser device
Read the detailed description
SPICE-CF is a non-commercial feasibility trial evaluating sputum induction using two different nebuliser devices in people with cystic fibrosis (CF) who are unable to spontaneously expectorate sputum.
With the increasing use of CFTR modulator therapies, many people with CF produce less spontaneous sputum. However, obtaining lower respiratory tract samples remains important for microbiological surveillance and clinical management. Sputum induction using nebulised hypertonic saline provides a non-invasive method of obtaining respiratory samples when spontaneous sputum is unavailable. There is currently limited evidence comparing nebuliser technologies for sputum induction in people with CF.
This is a prospective, randomised, open-label, two-period crossover feasibility trial comparing a jet nebuliser with the E-flow Rapid vibrating mesh nebuliser. Each participant will undergo sputum induction using both devices and will therefore act as their own control. The order of device use will be randomised, with a minimum two-week washout period between study visits.
Sputum induction will follow a standardised protocol using nebulised hypertonic saline together with physiotherapist supervised airway clearance. The primary focus of the study is to assess the feasibility of recruiting and retaining people with CF who are unable to spontaneously expectorate sputum in a randomised crossover trial comparing two nebuliser systems for sputum induction. The study will also assess the acceptability and deliverability of the procedures and collect preliminary information on successful sputum collection, procedure duration, participant experience, microbiological yield, and the use of a visual scoring system to characterise sputum colour and viscosity and differentiate sputum from saliva. The findings will help inform the design of a future definitive randomised controlled trial.
- Conditions
- Cystic Fibrosis (CF), Cystic Fibrosis Lung Disease
- Being tested
- Sputum induction
- Keywords
- sputum induction, cystic fibrosis, nebuliser, e-flow, jet nebuliser
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum inductionDiagnostic test
Also called induced sputum
Sputum induction is a non-invasive procedure used to obtain a lower respiratory tract sputum sample from individuals who are unable to expectorate sputum spontaneously. Participants inhale nebulised hypertonic saline (3% or 7%) to help mobilise airway secretions and stimulate sputum production. Nebulisation is performed in up to three five-minute periods and is combined with physiotherapist supervised airway clearance using the participant's usual airway clearance technique. Participants are encouraged to expectorate sputum throughout the nebulisation and airway clearance procedure for collection and subsequent microbiological analysis.
| Study group | Role | What they receive |
|---|---|---|
| Sputum induction completed via E-flow Rapid nebuliser device | Active comparator | Not described Receives: Diagnostic Test: Sputum induction |
| Sputum induction completed via jet compressor nebuliser device | Active comparator | Not described Receives: Diagnostic Test: Sputum induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of participant recruitment and retention
Feasibility will be assessed by the number of eligible participants who consent to participate and the number of enrolled participants who complete both study visits. Recruitment and retention rates will be calculated to determine the feasibility of conducting a future definitive randomised controlled trial comparing nebuliser devices for sputum induction in adults with cystic fibrosis.
Measured: From participant enrolment to completion of the second study visit, assessed up to 3 months from first visit
Secondary outcomes (4)
Successful sputum sample collection
Sputum induction success will be assessed as whether a sputum sample of at least 1 mL is successfully obtained during each sputum induction procedure (yes/no). Success will be recorded separately for sputum induction performed using the jet nebuliser and the E-flow Rapid nebuliser.
Measured: During sputum induction at Visits 1 and 2, assessed within 90 minutes per visit, up to 3 months after enrolment
Classification of collected samples as sputum or saliva
Collected samples will be assessed using a study-specific standardised visual sputum scoring system. Samples will be characterised using macroscopic features including colour and viscosity to determine the presence of sputum and differentiate sputum from saliva. Assessments will be performed independently by the physiotherapist and laboratory personnel using direct assessment and the corresponding video recording
Measured: Following sample collection at Visits 1 and 2, up to 3 months after enrolment
Participant-reported acceptability of sputum induction
Participant experience of sputum induction using each nebuliser device will be assessed using a study-specific questionnaire completed after each study visit. The questionnaire assesses participant preference, ease of use, comfort, tolerance, and overall acceptability. Responses will be recorded using a five-point Likert scale ranging from "strongly agree" to "strongly disagree", where appropriate.
Measured: Immediately following sputum induction at Visits 1 and 2, up to 3 months after enrolment
Duration of sputum induction procedure
The duration of the sputum induction procedure will be recorded for each nebuliser device. Procedure duration will be assessed separately for sputum induction performed using the jet nebuliser and the E-flow Rapid nebuliser.
Measured: During sputum induction at Visits 1 and 2, assessed within 90 minutes per visit, up to 3 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879651
- Sponsor's protocol ID
- 371802
- Acronym
- SPICE-CF
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Collins N. (2021) Guideline for Administration of Inhaled Medication for Sputum Induction in Cystic Fibrosis via Patient Specific Direction. Unpublished internal document. London: Royal Brompton Hospital.
Ahmad A., Simmonds N., Stanford G. (2026) Benchmarking sputum induction (SI) practice across UK cystic fibrosis (CF) centres. [Poster]. Royal Brompton Hospital, London.
Ahmad A., Tobin T., Stanford G., Simmonds N. (2025) "Another one?" - dealing with an increase in sputum induction referrals in a large adult uk cystic fibrosis (CF) centre: a quality improvement initiative. [Poster]. Royal Brompton Hospital, London.
European Cystic Fibrosis Society Clinical Trials Network (2024) Sputum Induction for Non-expectorating Older Children and Adults. Unpublished internal document. Unknown: European Cystic Fibrosis Society.
Flament MP, Leterme P, Gayot A. Study of the technological parameters of ultrasonic nebulization. Drug Dev Ind Pharm. 2001 Aug;27(7):643-9. doi: 10.1081/ddc-100107320.
PubMed 11694011Ratjen F, Bell SC, Rowe SM, Goss CH, Quittner AL, Bush A. Cystic fibrosis. Nat Rev Dis Primers. 2015 May 14;1:15010. doi: 10.1038/nrdp.2015.10.
PubMed 27189798Wong HH, Fahy JV. Safety of one method of sputum induction in asthmatic subjects. Am J Respir Crit Care Med. 1997 Jul;156(1):299-303. doi: 10.1164/ajrccm.156.1.9610114.
PubMed 9230765Hunter CJ, Ward R, Woltmann G, Wardlaw AJ, Pavord ID. The safety and success rate of sputum induction using a low output ultrasonic nebuliser. Respir Med. 1999 May;93(5):345-8. doi: 10.1016/s0954-6111(99)90317-7.
PubMed 10464902Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.
PubMed 19648517Wong LK, Barry AL, Horgan SM. Comparison of six different criteria for judging the acceptability of sputum specimens. J Clin Microbiol. 1982 Oct;16(4):627-31. doi: 10.1128/jcm.16.4.627-631.1982.
PubMed 7153311Oxford University Hospitals NHS Foundation Trust (2025) Sputum. Available at: https://www.ouh.nhs.uk/microbiology/a-z/sputum/
Davidson WJ, Dennis J, The S, Litoski B, Pieron C, Leigh R. Identification and validation of nebulized aerosol devices for sputum induction. Can Respir J. 2014 Mar-Apr;21(2):101-6. doi: 10.1155/2014/925305. Epub 2013 Nov 28.
PubMed 24288700Loh LC, Eg KP, Puspanathan P, Tang SP, Yip KS, Vijayasingham P, Thayaparan T, Kumar S. A comparison of sputum induction methods: ultrasonic vs compressed-air nebulizer and hypertonic vs isotonic saline inhalation. Asian Pac J Allergy Immunol. 2004 Mar;22(1):11-7.
PubMed 15366653Nie S, Wang L, Ma S, Sun H. Impact of silicone midline catheter tip location on catheter-related complications and indwelling duration: results from a multicentre randomised clinical trial in China. BMJ Open. 2025 Mar 12;15(3):e086717. doi: 10.1136/bmjopen-2024-086717.
PubMed 40074277Paggiaro PL, Chanez P, Holz O, Ind PW, Djukanovic R, Maestrelli P, Sterk PJ. Sputum induction. Eur Respir J Suppl. 2002 Sep;37:3s-8s. doi: 10.1183/09031936.02.00000302. No abstract available.
PubMed 12361361
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPICE-CF: Sputum Induction and Nebuliser Devices for Patients With Cystic Fibrosis - a Feasibility Trial
- ClinicalTrials.gov ID
- NCT07879651
- Acronym / sponsor ID
- SPICE-CF / 371802
- Conditions
- Cystic Fibrosis (CF), Cystic Fibrosis Lung Disease
- Keywords
- sputum induction, cystic fibrosis, nebuliser, e-flow, jet nebuliser
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the SPICE-CF feasibility trial is to learn whether it is feasible to recruit and retain people with cystic fibrosis (CF) who are unable to produce sputum spontaneously in a study comparing two different nebuliser devices for sputum induction. The study will also assess how acceptable and practical the sputum induction procedures are.
The main questions it aims to answer are:
- Is it feasible to recruit and retain people with cystic fibrosis in a study comparing two nebuliser devices for sputum induction?
- Can sputum be successfully obtained using each nebuliser device?
- How acceptable are the two nebuliser devices to participants?
- How long does sputum induction take with each device?
- What microorganisms are identified in sputum collected using each device?
- Can a visual scoring system be used to distinguish sputum from saliva and describe sputum characteristics?
Researchers will compare a jet nebuliser with an E-flow Rapid nebuliser. Each participant will undergo sputum induction using both devices, with the order in which the devices are used determined at random.
Participants will:
- Attend two study visits, separated by at least 2 weeks
- Receive a bronchodilator before sputum induction
- Inhale hypertonic saline using either the jet nebuliser or E-flow Rapid nebuliser
- Perform their usual airway clearance technique with supervision from a physiotherapist
- Have their lung function, oxygen levels, heart rate, and chest sounds monitored
- Provide sputum produced during the procedure for assessment and routine microbiological testing
- Complete a brief questionnaire about their experience and the acceptability of each nebuliser device
Detailed description
SPICE-CF is a non-commercial feasibility trial evaluating sputum induction using two different nebuliser devices in people with cystic fibrosis (CF) who are unable to spontaneously expectorate sputum.
With the increasing use of CFTR modulator therapies, many people with CF produce less spontaneous sputum. However, obtaining lower respiratory tract samples remains important for microbiological surveillance and clinical management. Sputum induction using nebulised hypertonic saline provides a non-invasive method of obtaining respiratory samples when spontaneous sputum is unavailable. There is currently limited evidence comparing nebuliser technologies for sputum induction in people with CF.
This is a prospective, randomised, open-label, two-period crossover feasibility trial comparing a jet nebuliser with the E-flow Rapid vibrating mesh nebuliser. Each participant will undergo sputum induction using both devices and will therefore act as their own control. The order of device use will be randomised, with a minimum two-week washout period between study visits.
Sputum induction will follow a standardised protocol using nebulised hypertonic saline together with physiotherapist supervised airway clearance. The primary focus of the study is to assess the feasibility of recruiting and retaining people with CF who are unable to spontaneously expectorate sputum in a randomised crossover trial comparing two nebuliser systems for sputum induction. The study will also assess the acceptability and deliverability of the procedures and collect preliminary information on successful sputum collection, procedure duration, participant experience, microbiological yield, and the use of a visual scoring system to characterise sputum colour and viscosity and differentiate sputum from saliva. The findings will help inform the design of a future definitive randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sputum induction completed via E-flow Rapid nebuliser device | Active comparator | Diagnostic Test: Sputum induction |
| Sputum induction completed via jet compressor nebuliser device | Active comparator | Diagnostic Test: Sputum induction |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of CF (confirmed by standard criteria)
- Sixteen years of age or over
Key exclusion criteria (18 listed)
- History of intolerance to hypertonic saline 3% or 7%
- Lung function impairment (<30%pp FEV1)
- Hypoxia (oxygen saturations of less than 90% on room air)
- Any haemoptysis within past 2 weeks
- Pneumothorax within 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sputum inductionAlso: induced sputumSputum induction is a non-invasive procedure used to obtain a lower respiratory tract sputum sample from individuals who are unable to expectorate sputum spontaneously. Participants inhale nebulised hypertonic saline (3% or 7%) to help mobilise airway secretions and stimulate sputum production. Nebulisation is performed in up to three five-minute periods and is combined with physiotherapist supervised airway clearance using the participant's usual airway clearance technique. Participants are encouraged to expectorate sputum throughout the nebulisation and airway clearance procedure for collection and subsequent microbiological analysis. | Diagnostic test | Sputum induction completed via E-flow Rapid nebuliser device, Sputum induction completed via jet compressor nebuliser device |
Primary outcome
Feasibility of participant recruitment and retention
Time frame: From participant enrolment to completion of the second study visit, assessed up to 3 months from first visit
Feasibility will be assessed by the number of eligible participants who consent to participate and the number of enrolled participants who complete both study visits. Recruitment and retention rates will be calculated to determine the feasibility of conducting a future definitive randomised controlled trial comparing nebuliser devices for sputum induction in adults with cystic fibrosis.
4 secondary outcomes
Successful sputum sample collection
Time frame: During sputum induction at Visits 1 and 2, assessed within 90 minutes per visit, up to 3 months after enrolment
Classification of collected samples as sputum or saliva
Time frame: Following sample collection at Visits 1 and 2, up to 3 months after enrolment
Participant-reported acceptability of sputum induction
Time frame: Immediately following sputum induction at Visits 1 and 2, up to 3 months after enrolment
Duration of sputum induction procedure
Time frame: During sputum induction at Visits 1 and 2, assessed within 90 minutes per visit, up to 3 months after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- BackgroundCollins N. (2021) Guideline for Administration of Inhaled Medication for Sputum Induction in Cystic Fibrosis via Patient Specific Direction. Unpublished internal document. London: Royal Brompton Hospital.
- BackgroundAhmad A., Simmonds N., Stanford G. (2026) Benchmarking sputum induction (SI) practice across UK cystic fibrosis (CF) centres. [Poster]. Royal Brompton Hospital, London.
- BackgroundAhmad A., Tobin T., Stanford G., Simmonds N. (2025) "Another one?" - dealing with an increase in sputum induction referrals in a large adult uk cystic fibrosis (CF) centre: a quality improvement initiative. [Poster]. Royal Brompton Hospital, London.
- BackgroundEuropean Cystic Fibrosis Society Clinical Trials Network (2024) Sputum Induction for Non-expectorating Older Children and Adults. Unpublished internal document. Unknown: European Cystic Fibrosis Society.
- Background: PubMed 11694011Flament MP, Leterme P, Gayot A. Study of the technological parameters of ultrasonic nebulization. Drug Dev Ind Pharm. 2001 Aug;27(7):643-9. doi: 10.1081/ddc-100107320.
- Background: PubMed 27189798Ratjen F, Bell SC, Rowe SM, Goss CH, Quittner AL, Bush A. Cystic fibrosis. Nat Rev Dis Primers. 2015 May 14;1:15010. doi: 10.1038/nrdp.2015.10.
- Background: PubMed 9230765Wong HH, Fahy JV. Safety of one method of sputum induction in asthmatic subjects. Am J Respir Crit Care Med. 1997 Jul;156(1):299-303. doi: 10.1164/ajrccm.156.1.9610114.
- Background: PubMed 10464902Hunter CJ, Ward R, Woltmann G, Wardlaw AJ, Pavord ID. The safety and success rate of sputum induction using a low output ultrasonic nebuliser. Respir Med. 1999 May;93(5):345-8. doi: 10.1016/s0954-6111(99)90317-7.
- Background: PubMed 19648517Murray MP, Pentland JL, Turnbull K, MacQuarrie S, Hill AT. Sputum colour: a useful clinical tool in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Aug;34(2):361-4. doi: 10.1183/09031936.00163208.
- Background: PubMed 7153311Wong LK, Barry AL, Horgan SM. Comparison of six different criteria for judging the acceptability of sputum specimens. J Clin Microbiol. 1982 Oct;16(4):627-31. doi: 10.1128/jcm.16.4.627-631.1982.
- BackgroundOxford University Hospitals NHS Foundation Trust (2025) Sputum. Available at: https://www.ouh.nhs.uk/microbiology/a-z/sputum/
- Background: PubMed 24288700Davidson WJ, Dennis J, The S, Litoski B, Pieron C, Leigh R. Identification and validation of nebulized aerosol devices for sputum induction. Can Respir J. 2014 Mar-Apr;21(2):101-6. doi: 10.1155/2014/925305. Epub 2013 Nov 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sputum induction in people with Cystic Fibrosis (CF) and Cystic Fibrosis Lung Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gemma Stanford, BSc (Hons), PhD (+44 20 7351 8071, gemma.stanford2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of participant recruitment and retention (time frame: From participant enrolment to completion of the second study visit, assessed up to 3 months from first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879651, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.