None listed
Conditions
Brief summary
We have previously demonstrated the effectiveness of a multidimensional assessment and individualised management approach in older people with obstructive airways disease, showing that such a programme leads to significant improvement in health outcomes. The current study aims to continue this new model of management in a different population of people with severe persistent asthma. People with severe persistent asthma continue to suffer a significantly high burden of disease despite maximal pharmacotherapy. Despite this, few trials seeking to improve management of severe asthma, have been performed. The current study aims to improve the management and outcomes for people severe persistent asthma, with the goal of reducing morbidity, improving health status and informing clinical guidelines. This study will aim to test a novel model of management in severe asthma using multidimensional assessment and individualised management (MDAIM) including inflammometry and case management. We hypothesize that treatment of severe asthma that is targeted to co-morbidities, inflammatory and other immunological biomarkers delivered using a case management approach will improve severe asthma outcomes specifically asthma control, exacerbations, medication use and health related quality of life.
Interventions
Participants in the intervention group will undergo a multidimensional assessment and individualised management (MDAIM) which aims to provide evidence based care through a case management approach, to people with severe persistent asthma. Assessment and treatment will be targeted to co-morbidities, inflammatory and other immunological biomarkers through a multidisciplinary case management approach and using inflammometry. The multidimensional assessment will involve 2 baseline assessments each o
Participants in the intervention group will undergo a multidimensional assessment and individualised management (MDAIM) which aims to provide evidence based care through a case management approach, to people with severe persistent asthma. Assessment and treatment will be targeted to co-morbidities, inflammatory and other immunological biomarkers through a multidisciplinary case management approach and using inflammometry. The multidimensional assessment will involve 2 baseline assessments each of approximately 2.5 hours duration. The tailored interventions will be standardised according to best available evidence and will include: optimal medical management including tailoring pharmacotherapy according to airway and systemic inflammation and guiding the exacerbation plan, individualised smoking cessation counselling and pharmacotherapy, management of anxiety and depression, management of mucous hypersecretion, exacerbation management, management of dysfunctional breathing, correction of nutritional and metabolic disorders, implementation of domiciliary oxygen, self management education and support, management of airflow obstruction and co-morbidities, correction of adherence, exercise training, treatment of infection, management of dyspnea, symptoms and patient identified problems. The intervention will be standardised and include 3 key features, a comprehensive assessment to determine the clinical problems and a tailored care plan and follow up. Whilst each participants care plan will differ the recommended interventions will be standardised. The frequency of clinical contact a participant will have may differ depending on the intervention received, however may range between once weekly to once monthly. Participants may be seen by more than one clinician in one week, however the appointments will occur in the same day, one after the other for participant convenience. The duration of the study will be 16 weeks and therefore intervention duration will be 16 weeks.
Sponsors
John Hunter Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Diagnosed with severe persistent asthma defined as uncontrolled asthma which can result in risk of frequent severe exacerbations (or death) and/or adverse reactions to medications and/or chronic morbidity including impaired lung function) on maximal treatment with inhaled corticosteroid and long-acting Beta2-agonist -Confirmed variable airflow obstruction at screening visit or documented within the past 10 years -Bronchodilator response >200ml OR > 12% (post-bronchodilator FEV1 following administration of 400mcg salbutamol, pMDI with spacer; after 10 minutes, or following administration of nebulised ventolin) -Airway hyperresponsiveness (in response to any standard challenge agent) -Peak flow variability >12% -FEV1 variability > 12% -If not observed, then hypertonic saline challenge at visit 1 (pD15 < 15mL saline). -Aged >18 years.
Exclusion criteria
-Aged < 18 years. -Treatment with any macrolide or tetracycline 4 weeks prior to screening. -Treatment with oral corticosteroids 4 weeks prior to screening (unless a low dose is being taken on a long-term basis: 10mg for >3 months) -Hypersensitivity to macrolides -Prolonged QTc > 0.44s at screening or during treatment -Taking medication that will interact with azithromycin in regard to QTc prolongation -Existing ECG abnormalities that may lead to arrhythmias -Pregnancy/breast feeding, likely to become pregnant or unwilling to use an additional form of contraception for the first 2 months of treatment if taking the oral contraceptive pill -Diagnosed with respiratory disease other than severe persistent asthma or bronchiectasis (e.g. active tuberculosis, pulmonary fibrosis) OR diagnosed with coexisting respiratory disease that, at investigator’s discretion, would adversely impact on study conduct. -Current lung cancer or other blood, lymphatic or solid organ malignancy -Inability to attend study visits -Impaired liver function at screening as shown by AST, ALT, alkaline phosphatase or total bilirubin > 1.5 times the upper limit of normal (During treatment if > 2 times the upper limit of normal) -Impaired renal function at screening as shown by Creatinine Clearance < 30mL/min -Ocular surgery within 3 months of study entry -Abdominal, chest or brain surgery within 3 months -Known cerebral, aortic, or abdominal aneurysm -Females of child-bearing potential, not using reliable contraception or unwilling to use a second method of contraception during the first 2 months of treatment if taking the oral contraceptive pill -Participants who have participated in another investigative drug study parallel to, or within 4 weeks of study entry
Outcome results
None listed