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Using FeNO to optimally manage asthma

Optimising the management of asthma using FeNO to direct the use of inhaled steroids: the OPTIMAN study. A real-life implementation of biomarker (FeNO) based diagnosis and management of asthma in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17718575
Enrollment
384
Registered
2019-11-14
Start date
2019-12-14
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Asthma Respiratory Asthma

Interventions

This is a study of the use of exhaled nitric oxide (FeNO) to both diagnose asthma and improve the outcomes for patients with asthma. The intervention is simply adding measurement of FeNO to the standa

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Either (i) newly presenting with a possible diagnosis of asthma or (ii) having been previously diagnosed with asthma and taking high dose inhaled corticosteroids 4. Able to use the NiOX FeNO monitoring equipment

Exclusion criteria

Exclusion criteria: 1. Cannot give informed consent 2. Unable to obtain a satisfactory FeNO level recording 3. Severe life-threatening condition or one that would be anticipated to lead to death or disability within 1 year of study period 4. Current history of primary lung malignancy or current active pulmonary TB 5. Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject's ability to participate in the study

Design outcomes

Primary

MeasureTime frame
Asthma control in the previous 2 weeks, assessed using the Asthma Control Test (ACT) at baseline, at 30 days and at 60 days and at 1 year.

Secondary

MeasureTime frame
All outcomes are measured at first visit, 30 days, 60 days and 360 days: 1. Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ) 2. Peak expiratory flow rate (PEFR) measured for 2 weeks, twice a day, after each visit; recorded on diary cards 3. Subject anxiety and depression measured using the Hospital Anxiety and Depression (HAD) questionnaire (self-administered) at each visit 4. Healthcare utilisation collected by the research team by taking a history from the patients and using primary care records 5. Changes to treatment (dose or drug) collected by the research staff from patient history as well as primary care records 6. Healthcare economic impact assessment performed using the data collected above by a professional healthcare economist 7. The number of asthma attacks (exacerbations) collected through interview and GP records 8. Disease-related healthcare mastery measured using the Healthcare Mastery score

Countries

England, United Kingdom

Contacts

Public ContactRichard;Emma Russell;Hedley

;

;emma.hedley@ndm.ox.ac.uk;+44 (0)1865 225205

Outcome results

None listed

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