Condition category
Respiratory
Date applied
04/09/2020
Date assigned
04/09/2020
Last edited
07/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.bedfont.com/

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

Publication citations

Additional files

Editorial Notes

07/09/2020: Ethics approval details updated. 04/09/2020: Trial's existence confirmed by School of Sport & Exercise Sciences Research Ethics and Advisory Group (REAG), University of Kent at Medway.