Plain English Summary
Background and study aims
Exhaled nitric oxide (FeNO) is widely known as a ‘breath biomarker’ for airway inflammation. This means that a nitric oxide sensor can detect the levels of FeNO from an individual. This allows medical practitioners to assess a patient’s airway inflammation to support diagnosis and management of airway diseases such as asthma. The aim of this study is to see whether Bedfont® Scientific’s FeNO analyser (NoBreath® V2) provides repeatable measurements when used by different practitioners. This study will also seek to monitor the change in FeNO levels between visits separated by 14 days.
Who can participate?
Healthy volunteers or patients with a history or current diagnosis of asthma, aged 7 or above
What does the study involve?
The study is likely to last 2-3 weeks with two visits. For the first visit, the researchers will take measurements of FeNO and lung function and then repeat these at the second visit. At each visit they will also ask the participant to complete an asthma control questionnaire if the participant currently has a diagnosis of asthma. For those participants who have a diagnosis of asthma the researchers will also assess the participant's inhaler technique at each visit.
What were the possible risks and benefits of participating?
Possible benefits of taking part in the study include identifying possible uncontrolled asthma so that appropriate steps to control asthma can be referred and taken by the relevant organisations. The study is deemed to be a low-risk study. The device used in the study is currently sold in the UK and in many other countries. The medical device currently holds a CE mark meaning it meets EU performance and safety standards. The procedures are not invasive and only require breath samples to be taken. Other procedures such as lung function measurements and questionnaires (and FeNO scores) are already recommended procedures to assist with asthma diagnosis in the UK, and are widely acknowledged and adopted around the world. The aim is to make the FeNO devices more accessible around the world and aid in the support of FeNO being used as a tool to aid to diagnose and manage asthma. There is a low chance that performing the lung function measurement may trigger an asthma response in participants with asthma. The labs will conform to all health and safety protocols to ensure chances of coming in contact with COVID-19 virus are as minimised as possible. This will involve the researcher and participant being asked to wear Personal Protective Equipment (PPE) where appropriate. This includes at a minimum, masks for the duration participants are on site. In addition, the lab spaces and equipment will be sanitised between participants. For each assessment participants will use single-use disposable mouthpieces that include filters.
Where is the study run from?
Bedfont® Scientific Ltd (UK)
When did the study start and how long is it expected to run for?
February 2020 to August 2020
Who is funding the study?
Bedfont® Scientific Ltd (UK)
Who is the main contact?
Hannah Vince-Drew
Hannah@bedfont.com
Trial website
Contact information
Type
Public
Primary contact
Mrs Hannah Vince-Drew
ORCID ID
Contact details
Station Road
Harrietsham
Maidstone
ME17 1JA
United Kingdom
+44 (0)1622 854866
hannah@bedfont.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
138.326
Study information
Scientific title
A method comparison study comparing intra- and inter-user reproducibility of FeNO measurement using the NObreath® V2
Acronym
Study hypothesis
1. To demonstrate a significant and clinically meaningful decrease in FeNO as a biomarker of inflammation, to evaluate an asthma subject's clinical response to approximately 14 days of inhaled and, in some participants, oral steroid therapy and to evaluate the intra-operator and inter-operator variability measured by the NObreath® v2.
2. To demonstrate that the change in FeNO after corticosteroid therapy is accompanied by improvement in spirometry, asthma symptoms, and asthma control questionnaire (ACQ) scores.
3. To assess the repeatability and variability of FeNO measured by the NO breath between practitioners on the same day and separated by 14 days.
Ethics approval
Approved 17/08/2020, School of Sport & Exercise Sciences Research Ethics and Advisory Group (REAG), (University of Kent at Medway, Medway Building, Central Ave, Gillingham, Kent, ME4 4AG, UK; +44 (0)1227 827833; ssesethics@kent.ac.uk), ref: 58_2019_20
Approved 12/05/2020, ethics committee platforma Brazil (Rua Dr. Almeida Lima, 1.134 - 2o andar - sala 207, Brazil; +55 (0)11 2790 4658; cep@anhembi.br), ref: not applicable
Study design
Open-label randomized multi-group and multi-centre study in adult and paediatric populations
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Asthma in adult and paediatric populations
Intervention
On the first visit, participants will complete FeNO analysis with three practitioners in a randomised order, spirometry, complete an asthma control questionnaire (ACQ) and have inhaler technique assessed (asthma participants only). Participants' respiratory health will be analysed using measurements from FeNO, spirometry and ACQ. Those whose respiratory function is deemed healthy or well-controlled asthma will have no intervention. Those who are deemed to have respiratory function suggestive of uncontrolled asthma (FeNO >25 adults ppb; >20 ppb children) will have inhaler technique training and be advised to visit their general practitioner for adjustment of prevention therapy. The second visit will repeat all the assessments from visit 1. Comparisons will be made between measurements taken by practitioners and between visits.
Intervention type
Device
Phase
Not Applicable
Drug names
FeNO analyser device second-generation NOBreath
Primary outcome measure
1. The repeatability and variability of FeNO measured by the second generation NObreath® by three practitioners with two repeats at baseline and after 14 days (±3 days) after therapeutic agents are administered
2. Asthma control measured using asthma control questionnaire (ACQ) at baseline and after 14 days (±3 days) after therapeutic agents are administered
3. FEV1/FVC measured with a spirometry device at baseline and after 14 days (±3 days) after therapeutic agents are administered
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/02/2020
Overall trial end date
30/08/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 7 years or above
2. If on allergy immunotherapy treatment this must be a stable regimen during the study
3. Be capable of producing valid FeNO measurements via the NObreath®
4. Be capable of performing spirometry in accordance with ATS/ERS criteria
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
200 participants (100 asthma; 100 healthy)
Total final enrolment
89
Participant exclusion criteria
1. Hospitalisation related to asthma in the past 6 months
2. Use of oral corticosteroid in the 4 weeks prior to visit 1
3. Use of biological therapies e.g. mepolizumab in 12 weeks prior to visit 1
4. Other respiratory diseases e.g. COPD or cystic fibrosis
5. Known intolerance to inhaled corticosteroids or salbutamol
6. Cardiovascular conditions:
6.1. Coronary artery disease
6.2. High blood pressure
6.3. Heart failure
6.4. Diagnosed abnormality of heart rhythm
7. A smoking history of >10 packs per year
8. Pregnant
Recruitment start date
30/07/2020
Recruitment end date
10/08/2020
Locations
Countries of recruitment
Brazil, United Kingdom
Trial participating centre
Bedfont Scientific Ltd
Station Yard
Station Road
Harrietsham
Maidstone
ME17 1JA
United Kingdom
Trial participating centre
Kent University
Medway Building
Central Ave
Gillingham
ME4 4AG
United Kingdom
Trial participating centre
Medway Asthma Self-Help (MASH)
131 Watling St
Gillingham
ME7 2YY
United Kingdom
Trial participating centre
Private office/clinic Dr Claudio Frison
Rua Paraibuna
811 -13º andar - sala 1302 Ed. Office 811
São José dos Campos
Sao Paulo
SP, 12245-020
Brazil
Trial participating centre
Private Clinic Elisa Coutinho
Rua Paraibuna 811 Sala 1302
São José dos Campos
Sao Paulo
SP, 12245-020
Brazil
Sponsor information
Organisation
Bedfont® Scientific Ltd
Sponsor details
Station Road
Harrietsham
Maidstone
ME17 1JA
United Kingdom
+44 (0)1622 854866
ask@bedfont.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bedfont® Scientific Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. The protocol can be made available on request on a case by case basis.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/09/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list