Adjustable and fixed dosing with budesonide/formoterol via a single inhaler in asthma patients: the ASSURE study

Patient-guided management of asthma using adjustable dosing of budesonide/formoterol in a single inhaler (Symbicort ®) was compared with fixed dosing in an open-label, multicentre, randomised study. Patients, uncontrolled on an inhaled corticosteroid (ICS) or controlled on an ICS and a long-acting β 2-agonist, entered a 4-week run-in period and received budesonide/formoterol (80/4.5 or 160/4.5 μg), 2 inhalations b.i.d. Following randomisation, the fixed-dosing group ( n=764) continued this regimen for a further 12 weeks. The adjustable-dosing group ( n=775) could step down to 1 inhalation b.i.d. if symptoms were controlled, and, at early signs of worsening symptoms, promptly step up to 4 inhalations b.i.d. for ⩽2 weeks. During run-in, National Heart, Lung and Blood Institute symptom-severity grading was maintained in 60% and improved in 31% of patients, clinic peak flow increased from 400 to 419 l/min ( P