The effect of adjustable dosing with budesonide/formoterol on health-related quality of life and asthma control compared with fixed dosing

Background: Budesonide/formoterol in a single inhaler is an effective therapy for asthma. We investigated whether adjustable maintenance dosing with budesonide/formoterol could maintain health-related quality of life (HROL) and asthma control. Patients/methods: Asthma patients (n = 4025) received budesonide/formoterol (Symbicort* 160/4.5mug) 2 inhalations twice daily (bid) for 4 weeks during run-in of this open, multicentre study. Patients were randomised to adjustable dosing (budesonide/formoterol 1 inhalation bid; stepping up to 2 or 4 inhalations bid for 1 week if asthma worsened) or fixed dosing (budesonide/formoterol 2 inhalations bid), for 12 weeks. Change in HROL (standardised Asthma Quality of Life Questionnaire, AQLQ[S], score) during randomised treatment was the primary efficacy variable. Secondary variables included asthma control (peak expiratory flow PEF symptom-severity score, nocturnal awakenings, reliever-medication use) and study-medication intake. Results: Clinically significant (greater than or equal to 0.5) improvements in AQLQ(S) score (mean 0.73), morning and evening PEF (mean 42.5 and 24.8 L/min, respectively), and symptom-severity score (mean 0.36) were achieved during run-in. The improvements were maintained in both groups although, overall, adjustable-dosing patients took fewer daily inhalations of budesonide/formoterol than fixed-dosing patients (mean 2.63 versus 3.82, p < 0.001). Conclusion: Adjustable maintenance dosing with budesonide/formoterol maintains HROL and asthma control as effectively as fixed dosing and is associated with a reduced drug load overall.