Early access
Sign in
Not yet taking people in United KingdomNo phase

Comparing two nebuliser devices to collect sputum from people with cystic fibrosis

Compares two nebuliser devices for collecting sputum in people with cystic fibrosis.

Key facts

Who runs it
Royal Brompton & Harefield NHS Foundation Trust
Where
London, United KingdomSee the site
Trial code
Registry title
SPutum Induction and Nebuliser deviCEs for Patients With CF
Status
Not yet recruiting
People taking part
30 people, planned
Started
Oct 2026
Expected to end
Jul 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Sputum induction
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 16 or over with cystic fibrosis who cannot produce sputum on their own. It compares two nebuliser devices used to bring up sputum.

Age
16 years or older
Sex
All sexes
Disease stage
Cystic fibrosis confirmed by standard criteria. Lung function (FEV1) of 30% predicted or more. No spontaneous sputum production.
Earlier treatment
No treatment for a lung flare-up (pulmonary exacerbation) within 21 days of the screening visit.

Main reasons for not taking part

  • Past intolerance to hypertonic saline 3% or 7%
  • Lung function (FEV1) below 30% predicted, or oxygen saturation below 90% on room air
  • Coughing up blood within the past 2 weeks, or a collapsed lung (pneumothorax) within 6 weeks
  • Pregnant or trying to conceive
  • Currently in another interventional medicinal study

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Diagnosis of CF (confirmed by standard criteria)
  • Sixteen years of age or over

Who cannot take part

  • Recent eye surgery within past 6 weeks
  • History of intolerance to hypertonic saline 3% or 7%
  • Lung function impairment (<30%pp FEV1)
  • Any known history or known family history of thoracic or cerebral aneurysm
  • 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
  • Acute pulmonary emboli (within 6 weeks)
  • Acute undifferentiated chest pain
  • Fractured ribs or other chest trauma in the 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

Where in United Kingdom

  • Royal Brompton HospitalLondon, United KingdomContact: Gemma Stanford, BSc (Hons), PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 2 groups in the trial

  • Sputum induction completed via E-flow Rapid nebuliser deviceExisting treatment, for comparison

    Treatment: Sputum induction

  • Sputum induction completed via jet compressor nebuliser deviceExisting treatment, for comparison

    Treatment: Sputum induction

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
SPICE-CF: Sputum Induction and Nebuliser Devices for Patients With Cystic Fibrosis - a Feasibility Trial
Plain-language title
Comparing two nebuliser devices to collect sputum from people with cystic fibrosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 October 2026