AsthmaFLAMENCT04182009
A Comparison of Two Nebulisers for Sputum Induction
A study testing Omron NE-U17 Ultrasonic nebuliser and Akita Jet Inhalation System in people with Asthma and COPD, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways. However, the procedure can be slightly uncomfortable for patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Omron NE-U17 Ultrasonic nebuliser and Akita Jet Inhalation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an ability to provide fully informed consent.
- Have a diagnosis of asthma or COPD.
- Male or female.
- Age between 18 to 75 years.
Who cannot join
- Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value.
- Have an exacerbation of asthma or COPD within the 30 days prior to the first visit.
- Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit.
- Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham Respiratory Research Unit
Nottingham, NG5 1PB
Dr Paula Almeida, PT, DHSc, 0115 9691169 ext. 58012, paula.almeida@nottingham.ac.uk
Katherine M Smith, BA(Hons), MA, 0115 8231911, katherine.m.smith@nottingham.ac.uk
About this study
Official title: A Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation
Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways.
However, the procedure can be slightly uncomfortable for patients. This study aims to assess the differences in participants' tolerability of sputum induction, by comparing two different nebulisers when performing the procedure.
Read the detailed description
This is a single centre, crossover study to compare the use of two nebulisers in the sputum induction procedure. 54 participants with stable asthma or COPD will be recruited and will attend 2 visits, at least 48 hours apart. Differences in the quality and quantity of samples and the time taken to produce a sample will be described. The main purpose is to explore the optimum device to perform the procedure, whilst protecting the safety of participants and maximising their comfort.
If participants are unable to produce a sputum sample after completion of the induction procedure, physiotherapy techniques may be performed. This is an exploratory objective to establish whether these techniques may help in the event of unsuccessful procedures.
- Being tested
- Omron NE-U17 Ultrasonic nebuliser, Akita Jet Inhalation System
- Keywords
- Asthma, COPD, Nebuliser, Sputum Induction, Safety, Tolerability, Quality, Quantity, Physiotherapy
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omron NE-U17 Ultrasonic nebuliserDevice
The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
Akita Jet Inhalation SystemDevice
The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
| Study group | Role | What they receive |
|---|---|---|
| Omron | Other | Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2. Receives: Device: Omron NE-U17 Ultrasonic nebuliser; Device: Akita Jet Inhalation System |
| Akita | Active comparator | Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2. Receives: Device: Omron NE-U17 Ultrasonic nebuliser; Device: Akita Jet Inhalation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The tolerability to sputum induction test
Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)
Measured: During the visit, after each cycle of nebulisation (each 5 minutes)
Secondary outcomes (7)
Spirometry
Measurement of lung function (FEV1 and FEV1%pred)
Measured: During the visit, up to 4 hours
Borg Scale
Measurement of dyspnoea levels
Measured: During the visit, up to 4 hours
The quality of sputum samples
The analysis of squamous contamination in the sample (if >40%), viability (>65% of life cells) and quality of slide for differential cells count
Measured: During the processing time, 2 hours
The quantity of sputum samples
How much sputum sample was produced of sufficient quality for processing
Measured: During the visit, up to 4 hours
Time to produce sample
The time in minutes required to produce a sputum sample sufficient for processing
Measured: During the visit, up to 30 minutes
Saline quantity
The amount of sterile saline required to produce a sputum sample sufficient for processing
Measured: During the visit, up to 30 minutes
Influence of Physiotherapy techniques
The influence of manual vibrations and Huff cough in producing a sputum sample after unsuccessful induction attempts
Measured: During the study visit, up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start17 Sep 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Tim W Harrison, MBBS, BSc, MD, MSc, Principal investigator, Professor and Honorary Consultant, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182009
- Sponsor's protocol ID
- 18010
- Acronym
- FLAME
- Status last verified
- Jun 2019
- First submitted
- 12 Jun 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation
- ClinicalTrials.gov ID
- NCT04182009
- Acronym / sponsor ID
- FLAME / 18010
- Keywords
- Asthma, COPD, Nebuliser, Sputum Induction, Safety, Tolerability, Quality, Quantity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Dec 2019 (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.
Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways.
However, the procedure can be slightly uncomfortable for patients. This study aims to assess the differences in participants' tolerability of sputum induction, by comparing two different nebulisers when performing the procedure.
Detailed description
This is a single centre, crossover study to compare the use of two nebulisers in the sputum induction procedure. 54 participants with stable asthma or COPD will be recruited and will attend 2 visits, at least 48 hours apart. Differences in the quality and quantity of samples and the time taken to produce a sample will be described. The main purpose is to explore the optimum device to perform the procedure, whilst protecting the safety of participants and maximising their comfort.
If participants are unable to produce a sputum sample after completion of the induction procedure, physiotherapy techniques may be performed. This is an exploratory objective to establish whether these techniques may help in the event of unsuccessful procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omron | Other | Device: Omron NE-U17 Ultrasonic nebuliser, Device: Akita Jet Inhalation SystemOmron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2. |
| Akita | Active comparator | Device: Omron NE-U17 Ultrasonic nebuliser, Device: Akita Jet Inhalation SystemAkita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have an ability to provide fully informed consent.
- Have a diagnosis of asthma or COPD.
- Male or female.
- Age between 18 to 75 years.
Key exclusion criteria (4 listed)
- Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value.
- Have an exacerbation of asthma or COPD within the 30 days prior to the first visit.
- Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit.
- Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study.
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 |
|---|---|---|
| Omron NE-U17 Ultrasonic nebuliserThe Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled. | Device | Akita, Omron |
| Akita Jet Inhalation SystemThe Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure. | Device | Akita, Omron |
Primary outcome
The tolerability to sputum induction test
Time frame: During the visit, after each cycle of nebulisation (each 5 minutes)
Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)
7 secondary outcomes
Spirometry
Time frame: During the visit, up to 4 hours
Borg Scale
Time frame: During the visit, up to 4 hours
The quality of sputum samples
Time frame: During the processing time, 2 hours
The quantity of sputum samples
Time frame: During the visit, up to 4 hours
Time to produce sample
Time frame: During the visit, up to 30 minutes
Saline quantity
Time frame: During the visit, up to 30 minutes
Influence of Physiotherapy techniques
Time frame: During the study visit, up to 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Asthma
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
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. This study is not recruiting at the moment.
Professor Tim W Harrison, MBBS, BSc, MD, MSc principal investigator
Professor and Honorary Consultant, University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omron NE-U17 Ultrasonic nebuliser and Akita Jet Inhalation System in people with Asthma and COPD, run by University of Nottingham 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Paula Almeida, PT, DHSc (0115 9691169 ext. 58012, paula.almeida@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The tolerability to sputum induction test (time frame: During the visit, after each cycle of nebulisation (each 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2019.