An interventional study of Sputum induction in Cystic Fibrosis (CF) and Cystic Fibrosis Lung Disease, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Not applicable, Interventional, and Treatment
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:
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:
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.
1,605 studies on the registry are indexed under Cystic Fibrosis; 196 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Diagnostic Test: Sputum induction
Diagnostic Test: Sputum induction
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.
Also known as: induced sputum
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.
Time frame: From participant enrolment to completion of the second study visit, assessed up to 3 months from first visit
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.
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
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
Time frame: 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.
Time frame: 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.
Time frame: During sputum induction at Visits 1 and 2, assessed within 90 minutes per visit, up to 3 months after enrolment
Microbiological yield of induced sputum samples
Induced sputum samples successfully obtained using each nebuliser device will undergo routine microbiological analysis for cystic fibrosis relevant respiratory pathogens. Analysis will include routine microbiology culture and sensitivity (MC\&S) and non-tuberculous mycobacteria (NTM) testing
Time frame: Samples collected at Visits 1 and 2, up to 3 months after enrolment; results assessed following laboratory processing
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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