None listed
Conditions
Brief summary
Asthma attacks are a leading cause of hospitalisation and health inequity in New Zealand, particularly for Maori and Pacific peoples. Current guidelines recommend oral steroids (prednisone) for all asthma attacks, even though research shows that not all attacks are caused by the type of airway inflammation that steroids treat — meaning some people are receiving steroids they may not need. Long-term or repeated steroid use is associated with serious health problems including diabetes and cardiovascular disease. This study tests whether two simple tests - a finger-prick blood test for eosinophils (a type of immune cell) and a breathing test measuring airway inflammation (FeNO) - can safely identify which patients are likely to benefit from steroids and which are not. Adults who present to their GP with an asthma attack will be randomly allocated to one of two groups: the 'biomarker-guided' group, where steroid treatment is given only if the tests show high inflammation, or the 'standard care' group, which receives the usual 5-day steroid course regardless of test results. We hypothesise that biomarker-guided care will safely reduce unnecessary steroid use while maintaining patient safety.
Interventions
Brief name: Point-of-care (POC) biomarker-guided OCS dosing
Materials: (1) HemoCue® WBC DIFF point-of-care cell counter for blood eosinophil measurement; (2) NIOX VERO® device or other similar device for Fractional Exhaled Nitric Oxide (FeNO) measurement; (3) oral prednisone tablets 40 mg (for T2-high participants); (4) ICS escalation (for T2-low participants); (5) participant Asthma Action Plan.
Procedures: At point of presentation with an acute asthma attack, a trained practice nurse or clin
Brief name: Point-of-care (POC) biomarker-guided OCS dosing Materials: (1) HemoCue® WBC DIFF point-of-care cell counter for blood eosinophil measurement; (2) NIOX VERO® device or other similar device for Fractional Exhaled Nitric Oxide (FeNO) measurement; (3) oral prednisone tablets 40 mg (for T2-high participants); (4) ICS escalation (for T2-low participants); (5) participant Asthma Action Plan. Procedures: At point of presentation with an acute asthma attack, a trained practice nurse or clinician performs: (a) a finger-prick capillary blood draw (~20 µL) for eosinophil count via HemoCue® : results available in 2–5 minutes; (b) a slow, controlled exhalation manoeuvre into the NIOX VERO® device for FeNO measurement: result in ~2 minutes. Biomarker results are interpreted using a pre-specified algorithm: HIGH if blood eosinophils >=0.3×10^9/L, OR FeNO >=25 ppb, OR both eosinophils >=0.15×10^9/L AND FeNO >=20 ppb. T2-HIGH participants receive oral prednisone 40 mg/day for 5 days. T2-LOW participants (below all thresholds) receive ICS escalation consisting of quadrupling the participant's current prescribed ICS dose for 7 days, For participants prescribed ICS monotherapy, the dose of their existing inhaler will be quadrupled (e.g. from 200 µg to 800 µg budesonide daily). For participants prescribed ICS/formoterol combination inhalers, the increase will be to a max equivalent of budesonide/formoterol 400/12 µg up to 4× daily with a formoterol cap, consistent with current evidence for non-eosinophilic attacks. Who delivers: Practice nurse or GP at the primary care clinic. Clinical staff will receive standardised training in device operation, finger-prick technique, algorithm interpretation, and safety monitoring prior to site initiation. Mode: Face-to-face, individual, at the participating primary care practice. Frequency/duration: Single assessment at the point of the attack - the point-of-care testing is expected to take no longer than 10 minutes total. Medication treatment (prednisone 40 mg oral once daily) for 5 days. ICS escalation for the duration of the attack episode. OCS/ICS adherence will be determined by participant self-report. Location: Five general practice clinics across Auckland (Tamaki Makaurau) and Waikato regions, New Zealand. Personalisation: The intervention is explicitly personalised: OCS is prescribed only if T2-inflammatory biomarkers exceed pre-specified thresholds. This tailoring is the core of the intervention. Fidelity: Intervention fidelity will be monitored through structured site logs recording proportion of eligible patients tested, biomarker results recorded, and treatment prescribed per algorithm. Deviations will be documented in the eCRF.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged >=18 years with physician-diagnosed asthma - Presenting to a participating primary care practice with a current, acute asthma attack, defined by ATS/ERS criteria as meeting at least two of: (1) >=48 hours of symptoms not resolving despite increased inhaled therapy, AND (2) physician or patient decision to initiate a burst of oral corticosteroids - Currently prescribed an ICS-containing inhaler (maintenance and/or when required as part of an anti-inflammatory reliever (AIR) regimen)
Exclusion criteria
- COPD or other chronic lung disease; current smoker or >10 pack-year smoking history - Current use of maintenance oral corticosteroids, or any systemic corticosteroid use in the previous 4 weeks - Current treatment with biologic therapy (e.g. mepolizumab, omalizumab, benralizumab) - Known adrenal insufficiency or other contraindication to corticosteroid therapy - Pregnancy or breastfeeding - Life-threatening or severe asthma attack, defined as peak expiratory flow (PEF) or FEV1 <50% of best/predicted, or requiring ambulance treatment - Previous ICU admission for asthma - Significant comorbidity that would materially affect study participation or interpretation of outcomes
Outcome results
None listed