Minimising Oral Corticosteroid Use in Asthma using Treatable Traits
A treatable traits model-of-care versus enhanced usual care in adults with asthma to assess cumulative oral corticosteroid dose over the 52 week trial.
University of Newcastle
300 participants
May 6, 2024
Interventional
Conditions
Summary
Asthma is a common disease and significant public health problem in Australia, affecting one in nine adults. Current asthma management approaches treat all patients the same, using a step up- step down approach, which fails to recognise the complexity and heterogeneity that is evident, particularly in those with more severe disease. While this approach significantly improved asthma outcomes, in the early 21st century its limitations have become apparent, as improvements in asthma outcomes have stalled. Indeed, people continue to die from asthma, have an ongoing burden from acute attacks and symptoms, and suffer severe iatrogenic consequences of treatment, in particular from oral corticosteroids (OCS). Alarmingly, in Australia it has been demonstrated that more than 25% of patients using inhaled corticosteroids reach a cumulative OCS dose of >1000mg which is associated with increased risk of serious adverse side effects and irreversible harm. Management approaches that address the heterogeneity of asthma, including risk factors and comorbidities associated with the prevalence and persistence of the disease, and that incorporate advances in knowledge are urgently needed. “Treatable Traits” have been proposed as a useful concept to implement precision medicine. This approach recommends an assessment of traits or disease characteristics that fall within three domains: pulmonary, extra pulmonary and risk factor/behavioural, and the application of targeted individualised interventions based on the identified traits. This project will test the clinical and cost-effectiveness of a Treatable Traits model-of-care as an OCS-sparing strategy for the management of adults with asthma, while gathering information on its potential for implementation in real-world settings.
Eligibility
Inclusion Criteria6
- Able to provide written informed consent
- Aged 18 years or over
- Doctor diagnosis of asthma
- Asthma diagnosis for at least 18 months
- Prescribed treatment for doctor-diagnosed asthma.
- Have a cumulative OCS dose greater than or equal to 500mg over the previous 24 months (self-reported).
Exclusion Criteria7
- Current lung cancer or other blood, lymphatic or solid organ malignancy.
- Cognitive impairment, poor English language skills or significant untreated hearing impairment that prevents completion of data collection forms or understanding verbal instructions.
- Inability to attend study visits.
- High dependence on medical care.
- Significant life-limiting comorbidity (<12 months life expectancy)
- Current participation in any other clinical trial, or participation in another clinical trial within the 4 weeks preceding study entry.
- Currently Pregnant or breastfeeding
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The intervention is a 24-week individualised treatment programme consisting of three key components: 1. A Multidimensional Assessment (MDA). Participants will undergo assessments of 12 pulmonary (including blood collection), extra-pulmonary and risk-factor/behavioural traits that relate to asthma exacerbations and oral corticosteroid use, and that are feasible to assess and manage. This assessment will be completed by the Clinical Research Officer and will take approximately 2.5 hours to complete. 2. An individualised multidisciplinary treatment plan will be developed by the MDT guided by the results of the MDA and a biomarker-driven inflammatory treatment-decision algorithm that involves interventions targeted to the identified traits. Targeted treatments are standardised according to best available evidence. Participants will only receive the targeted treatment if that trait is identified. This plan will be developed within 2 weeks of the MDA. 3. A respiratory case-manager. The case-manager will summarise the traits identified, co-ordinate a case discussion with the multidisciplinary team (MDT), communicate the list of traits identified with each individual participant, communicate the treatment plan to the patient, provide education regarding the traits and the individualised treatments, co-ordinate the visits between the members of the MDT, and deliver the case manager interventions. Other members of the MDT will include a physician , speech pathologist and other appropriately trained clinicians. The number of visits over the 24 week intervention period is estimated to be up to 4 visits per participant .The total contact time for the intervention visits is estimated to be 3 hours per participant. The visits will be conducted face to face or via telehealth. The following traits will be targeted in this study: 1. Sub-optimal adherence Assessment: Self-report <80% of treatment by open-ended questions. Test of Inhaler Adherence Questionnaire Intervention: Tailored based on reasons for nonadherence including simplification of medication regimen, and education. This will be delivered by the Case Manager. 2. Inadequate inhaler device technique Assessment: Observation and assessment. Intervention: Education and training delivered by the Case Manager. 3. Inhaler device polypharmacy Assessment: Greater than 2 different inhaler device types. Intervention: Optimise inhaler technique and rationalise number of devices used. This will be delivered by the Case Manager and Doctor. 4. No written asthma action plan (WAAP) Assessment: WAAP not prescribed or used. Intervention: Provision of WAAP. This will be delivered by the Doctor. 5. Eosinophilic Airway inflammation Assessment: Blood eosinophils greater than or equal to 0.3 x 10^9/L Intervention: Step 1: Optimise Inhaled Corticosteroid use, Step 2: PBS approved monoclonal antibody OR Azithromycin if ineligible for PBS approved monoclonal antibody. This will be delivered by the Doctor. 6. Airflow limitation Assessment: FEV1 <80% predicted. Intervention: Long acting beta2-agonists +/- Long- acting muscarinic antagonist. This will be delivered by the Doctor. 7. Frequent chest infection Assessment: Greater than or equal to 2 courses of antibiotics per year. Intervention: Antibiotic tailored action plan and self- management education. E.g. Azithromycin 500mg three times per week. This will be delivered by the Doctor. 8. Frequent Exacerbations Assessment: Greater than or equal to 2 courses of OCS/year OR A cumulative OCS greater than or equal to 500mg over the past 24 months. Intervention: SMART Therapy (budesonide/formoterol). This will be delivered by the Doctor. 9. Vocal Cord Dysfunction Assessment: If Pittsburgh VCD Score greater than or equal to 4, then laryngoscopy. Intervention: Multicomponent intervention comprised of education, vocal fold release & vocal hygiene. This will be developed by the Speech Pathologist. 10. Rhinitis Assessment: SNOT questionnaire score >40. Intervention: Step 1. Determine rhinitis severity. Step 2: Trigger avoidance, intranasal steroids, antihistamines, and saline washes. Step 3. Referral to Specialist. This will be delivered by the Doctor. 11. Dysfunctional breathing Assessment: Nijmegen Score greater than or equal to 19 OR mMRC score greater than or equal to 1. Intervention: Breathing retraining. This will be delivered by the Case Manager or qualified clinician. 12. Smoking Assessment: Admit to smoking or exhaled CO greater than or equal to 10 ppm Intervention: Smoking cessation counselling +/- pharmacotherapy. This will be delivered by the Case Manager and Doctor.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000533594