Budesonide/formoterol maintenance and reliever therapy in asthma control: Acute, dose‐related effects and real‐life effectiveness. Issue 2 (3rd November 2014) - Lin, Ching‐Hsiung
Abstract Background and objective The efficacy of budesonide/formoterol maintenance and reliever therapy (BFMRT) in asthma control is well documented in large randomized controlled trials. However, the acute reliever effects and real‐life effectiveness are seldom reported. Methods This multicenter trial enrolled steroid‐naïve, symptomatic asthmatics with baseline exhaled nitric oxide (eNO) of ≥40 ppb. There were 120 eligible patients who were randomized and received a dose of inhaled budesonide/formoterol 320/9 μg (lower dose budesonide/formoterol), 640/18 μg (higher dose budesonide/formoterol (HDBF)), or terbutaline (TERB) 1 mg. Inflammatory cells and mediators in induced sputum, eNO and lung function were measured at baseline and 6 h (acute phase). Subsequently, all patients used BFMRT as real‐life practice for 24 weeks (maintenance phase). Results In the acute phase, the degree of post‐treatment reduction in total eosinophil counts, interleukin‐8 and matrix metalloproteinase‐9 in induced sputum were significantly greater in group HDBF (vs TERB, P < 0.05). The increase in forced expiratory volume in first second (FEV1) in group HDBF was significantly higher (vs LDBF and TERB, P < 0.05) 3 h after dosing. In the maintenance phase, significant improvement of asthma control (presented by eNO, FEV1 and a five‐item asthma control questionnaire) in real‐life settings was observed at 4 weeks and sustained to the end of study. The rate of patients who followed scheduled visits declined over time (87% at week 4 and 42% at week 24). Conclusions Budesonide/formoterol as reliever exerts acute, dose‐related anti‐inflammatory effects and FEV1 improvement in symptomatic asthmatics. BFMRT is effective in asthma control. However, the decrease in long‐term follow‐up rate remains an issue to overcome in real‐life settings.