Description of a randomised controlled trial of inhaled corticosteroid/fast-onset LABA reliever therapy in mild asthma

This paper describes the rationale and design of the Novel START (Symbicort Turbuhaler Asthma Reliever Therapy) randomised controlled trial of inhaled corticosteroid (ICS)/fast-onset long-acting β agonist (LABA) reliever therapy in mild asthma. The main focus of clinical research and management in asthma is on patients with moderate or severe asthma. There is little attention paid to the “silent majority” with asthma who experience so-called intermittent and mild persistent asthma. These patients are often taking inhaled short-acting β agonist (SABA) therapy alone, to provide symptom relief. However, while use of SABA therapy alone does provide symptom relief, there is little robust evidence supporting the long-term efficacy and safety of treating mild asthma with a SABA alone, or to guide clinicians and patients when to initiate regular low-dose ICS therapy. Further, doctors and patients find it difficult to recognise the need for ICS therapy when symptoms are infrequent and in this situation poor adherence to ICS is common. This has led to consideration of alternative regimens to regular ICS prescription for intermittent or mild asthma.