Temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations: FAST

• Published in: Health technology assessment (Winchester, England) England), 2018-12, Vol.22 (70), p.1-82
• Main Authors: McKeever, Tricia, Mortimer, Kevin, Bradshaw, Lucy, Haydock, Rebecca, Pavord, Ian, Higgins, Bernard, Walker, Samantha, Wilson, Andrew, Price, David, Thomas, Mike, Devereux, Graham, Brightling, Christopher, Renwick, Charlotte, Parrott, Steve, Mitchell, Eleanor, Duley, Lelia, Harrison, Tim
• Format: Article
• Language: English
• Subjects: Adrenal Cortex Hormones - administration & dosage; Adrenal Cortex Hormones - economics; Anti-Asthmatic Agents - administration & dosage; Anti-Asthmatic Agents - adverse effects; Anti-Asthmatic Agents - economics; asthma; Asthma - drug therapy; Asthma - economics; Asthma - prevention & control; Cost-Benefit Analysis; Dose-Response Relationship, Drug; exacerbation; Female; four-fold; Humans; inhaled corticosteroids; Male; Middle Aged; oral steroids; primary care; Quality of Life; randomised controlled trial; Self-Management; self-management plan; Technology Assessment, Biomedical; United Kingdom
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta22700

Asthma exacerbations affect the quality of life of patients with asthma and have a major effect on the overall costs of asthma care. An asthma self-management plan that advises the temporary quadrupling of inhaled corticosteroid dose may prevent asthma exacerbations, but this needs to be confirmed before being adopted widely. To compare the clinical effectiveness and cost-effectiveness of an asthma self-management plan that advises patients to temporarily quadruple the dose of inhaled corticosteroid when asthma control starts to deteriorate with a standard self-management plan. A multicentre, parallel-group, pragmatic randomised trial, with follow-up for 12 months. Primary and secondary care across 207 sites in the UK. Asthma patients aged ≥ 16 years treated with an inhaled corticosteroid who had experienced at least one exacerbation in the previous 12 months. Participants were randomised (1 : 1) to a usual-care self-management plan or to a modified self-management plan that advised a temporary quadrupling of the inhaled corticosteroid at the point of asthma deterioration, both of which were actively implemented and supported by local research staff. The primary outcome of 'time to first asthma exacerbation' was defined as the need for systemic corticosteroids (for at least 3 consecutive days) and/or unscheduled health-care consultations for asthma (i.e. reaching zone 3 or 4 of the Asthma UK self-management plan). A total of 1922 participants were randomised: the primary analysis included 938 participants (97%) in the usual-care group and 933 participants (97%) in the modified self-management group. The number of participants having at least one exacerbation of asthma in the year after randomisation was 484 (51.6%) in the usual-care group and 420 (45.0%) in the modified self-management group [adjusted hazard ratio 0.81, 95% confidence interval (CI) 0.71 to 0.92;  = 0.002]. There were fewer serious adverse events reported in the modified self-management group than in the usual-care group (11 vs. 32, respectively). Eight and six events of pneumonia, lower respiratory tract infections or influenza were reported in the usual-care group and the modified self-management group, respectively. Health-care-related costs were lower in the modified self-management group. The modified self-management group was £24 (bootstrapped 95% CI -£122 to £71) less costly than usual care, with a greater quality-adjusted life-year gain of 0.02 (bootstrapped 95% CI -0.005 to 0.04).