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Budesonide/formoterol maintenance and reliever therapy via T urbuhaler versus fixed‐dose budesonide/formoterol plus terbutaline in patients with asthma: Phase III study results
Author(s) -
ATIENZA TITO,
AQUINO TERESITA,
FERNÁNDEZ MARCELO,
BOONSAWAT WATCHARA,
KAWAI MITSURU,
KUDO TAKAHIDE,
Ekelund Jan,
Ivanov Stefan,
Carlsson LarsGoran
Publication year - 2013
Publication title -
respirology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.857
H-Index - 85
eISSN - 1440-1843
pISSN - 1323-7799
DOI - 10.1111/resp.12009
Subject(s) - budesonide , formoterol , medicine , budesonide/formoterol , terbutaline , tolerability , exacerbation , anesthesia , bronchodilator , maintenance therapy , asthma , inhalation , adverse effect , chemotherapy
Background and objective To evaluate the efficacy and tolerability of budesonide/formoterol as maintenance and reliever therapy versus budesonide/formoterol maintenance plus terbutaline in adults with persistent asthma not adequately controlled with inhaled corticosteroid ( ICS ) therapy alone. Methods In this 12‐month, randomized, double‐blind, parallel‐group, phase III study ( NCT 00839800), patients (age ≥16 years; receiving maintenance ICS ; ≥1 severe exacerbation in the 12 months prior to study entry) were randomized to either budesonide/formoterol 160/4.5 μg 1 inhalation twice daily plus budesonide/formoterol 160/4.5 μg as‐needed or budesonide/formoterol 160/4.5 μg 1 inhalation twice daily plus terbutaline 0.4 mg as‐needed for 12 months. Primary outcome: time to first severe asthma exacerbation; secondary outcomes included: lung function, asthma symptom variables and tolerability. Results Two thousand and ninety‐one patients were randomized: 170 (16%) receiving budesonide/formoterol maintenance and reliever therapy experienced 259 severe exacerbations versus 229 patients (22%) receiving budesonide/formoterol plus terbutaline who experienced 363 severe exacerbations. Budesonide/formoterol maintenance and reliever therapy prolonged the time to first severe exacerbation versus budesonide/formoterol plus terbutaline ( P = 0.0007) and reduced the instantaneous risk of an exacerbation by 30% (hazard ratio 0.70, 95% confidence interval 0.57–0.85, P = 0.0003). Times to first oral steroid use, first hospitalization and first emergency room treatment were all significantly prolonged in the budesonide/formoterol maintenance and reliever group versus budesonide/formoterol plus terbutaline. Both treatment groups were well tolerated. Conclusions Budesonide/formoterol maintenance and reliever therapy provided more effective asthma control, including a prolonged time to first severe asthma exacerbation, than budesonide/formoterol plus terbutaline and was well tolerated. Budesonide/formoterol maintenance and reliever therapy also improved lung function and asthma symptoms.