Asthma Respiratory
Conditions
Interventions
The control arm will receive standard of care and follow routine primary care.
Participants in the FeNO (intervention) arm will have their FeNO measured at baseline and at 12 month follow up.
Rando
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 12 years or above 2. On general practice asthma register AND meets one or more of the following criteria: 2.1 Currently prescribed inhaled corticosteroids on fixed dose or Maintenance and Reliever Therapy (MART) regimen 2.2 Three or more prescriptions for inhaled short-acting ß2-agonists in the last year 2.3 One or more exacerbations of asthma in the last year* 3. Permanently registered at participating GP surgery 4. Patient is willing and able to give informed consent or assent** for participation in the study *Exacerbations of asthma will be defined as per the primary outcome definition **Patients aged 16 years or over will be required to give informed consent. Patients aged 12 to 15 years inclusive will be required to give informed assent. Informed consent from a parent or legal guardian will also be required for participants aged 12 to 15 years inclusive.
Exclusion criteria
Exclusion criteria: 1. Receiving oral corticosteroids or biologics as maintenance treatment for asthma. Biologics will include omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, plus any further biologic agents which may be licensed for use in asthma during the course of the study. 2. Being managed in or awaiting assessment by a specialist asthma clinic 3. Currently coded as having ‘suspected asthma’ 4. Known contraindication to treatment with corticosteroids 5. Unable or unwilling to be followed up for 12-month period after the baseline asthma review. The baseline asthma review will be the first asthma review conducted after informed consent or assent for study participation has been obtained. 6. Insufficient ability to speak or understand English 7. Treated with systemic corticosteroids or antibiotics for an acute exacerbation of asthma during the 2-week period before baseline. Health care professionals will be advised to postpone a patient’s baseline asthma review if a patient has an acute exacerbation or has not yet recovered from an acute exacerbation by the time the review is scheduled. Health care professionals will be advised to consult the research team if they postpone a patient’s baseline asthma review to a date more than 4 weeks after consent/assent was obtained. 8. Had a change in their asthma medication in the past 4 weeks. Health care professionals may postpone a patient’s baseline asthma review if their asthma medication is changed after consent/assent is obtained but before their baseline asthma review is due to take place. Health care professionals will be advised to consult the research team if they postpone a patient’s baseline asthma review to a date more than 4 weeks after consent/assent was obtained. 9. Taking part in another study involving any intervention for asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with one or more acute asthma exacerbations between baseline asthma review and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of acute exacerbations of asthma (count data, nr.) between baseline asthma review and 12 months 2. Defined daily doses between baseline asthma review and 12 months 3. Proportion of participants whose anti-inflammatory asthma medications are stepped up or stepped down between baseline asthma review and 12 months 4. Medication Adherence Rating Scale for Asthma (MARS-A) 5 item version score at baseline, 3 months and 12 months 5. Medication Possession Ratio between baseline asthma review and 12 months 6. Defined daily doses and proportions of participants who are high SABA users between baseline asthma review and 12 months 7. Peak expiratory flow rate at baseline and 12 months 8. Asthma Control Test (ACT) score at baseline and 3, 6, 9 and 12 months 9. Proportion of patients with one or more adverse events potentially consistent with asthma or other related respiratory or allergic conditions which are felt to be clinically severe based on the clinician’s judgement between baseline asthma review and 12 months 10. Number of adverse events potentially consistent with asthma or other related respiratory or allergic conditions which are felt to be clinically severe based on the clinician’s judgement between baseline asthma review and 12 months. | — |
Countries
England, United Kingdom
Contacts
Public ContactLouise;Louise Jones;Jones
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Outcome results
None listed