Measuring changes in FeNO using the second generation Nobreath® device before and after medication for persons with asthma and observing whether FeNO results are consistent when taken by different people

A method comparison study comparing intra- and inter-user reproducibility of FeNO measurement using the NObreath® V2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55359097

Enrollment

200

Registered

2020-09-04

Start date

2020-07-30

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in adult and paediatric populations Respiratory Asthma

Interventions

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 asses

>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 vi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures	—

Countries

Brazil, England, United Kingdom

Contacts

Public ContactHannah Vince-Drew

hannah@bedfont.com+44 (0)1622 854866

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026