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| |  Budesonide/Formoterol Comparing With Budesonide and Theophylline in Japanese Adult Patients With Asthma: Presented at ERS By Chris Berrie BERLIN -- October 9, 2008 -- A fixed-dose combination of budesonide and formoterol is well tolerated and more effective for asthma control than a fixed-dose combination of budesonide and sustained-release (SR) theophylline according to a multicentre, randomised, double-blind, parallel-group, phase 3 study. Principal investigator Ken Ohta, MD, PhD, Department of Respiratory Medicine, Tokyo University School of Medicine, Tokyo, Japan, presented the findings here on October 7 at the European Respiratory Society (ERS) 18th Annual Congress. Both the Global Initiative for Asthma and Japanese treatment guidelines recommend a step-wise increase in therapy for management of asthma, with the addition of a long-acting beta2-agonist to initial moderate doses of inhaled corticosteroids (ICS). Dr. Ohta instead indicated, however, that a fixed-dose combination of the ICS budesonide and the long-acting beta2-agonist formoterol has been shown to be more effective for asthma management than the ICS budesonide alone. "In Japan we only have one combination agent so far, and this was newly introduced a year ago." Thus, this budesonide and formoterol combination is not currently approved for use in Japan, so the objective of this study was to confirm the efficacy and tolerability of fixed-dose budesonide/formoterol for 8 weeks in comparison with budesonide/theophylline SR in Japanese patients with asthma. Subjects were outpatients with documented asthma history of 6 months or more and forced expiratory volume in 1 second (FEV1) of 50% or greater predicted. Prior to enrolment, these patients were required to be taking ICS 400 to 800 mcg/day for 12 weeks and theophylline SR 400 mg/day for 8 weeks or more; these doses needed to have been constant for 4 weeks or more. After a 2-week run-in period, 178 patients were randomised to receive fixed-dose budesonide/formoterol 160/4.5 mcg with 1 inhalation twice daily and 170 patients to receive budesonide 200 mcg with 1 inhalation twice daily plus theophylline SR 200 mg as 1 tablet twice daily. Mean ages in the 2 groups were 50 and 48 years, respectively, and males made up 40% and 35%, respectively. Treatment efficacy measures included peak expiratory flows in the morning (mPEF) and evening (ePEF), with the primary variable being the change in mPEF from the run-in period. Severity according to the asthma symptom score was also recorded. Patients' clinical characteristics in the 2 treatment groups were similar for duration of asthma (13 and 12 years, respectively), ICS at study entry (655 and 664 mcg, respectively); FEV1 percent predicted (73 for each), mPEF (329 and 323 L/min, respectively), ePEF (337 and 328 L/min, respectively), and total asthma symptom score (1.24 and 1.32, respectively). For the primary efficacy measure of mPEF, fixed dose budesonide/formoterol achieved significant improvements over budesonide/theophylline SR, with an adjusted mean difference of 8.8 L/min (P = .0051). A similar significant improvement was seen for ePEF, with an adjusted mean difference of 6.2 L/min (P = .0355). Total asthma symptom scores decreased over the 8 weeks, although the reductions were not significantly different between these 2 treatment arms. Overall, both treatments were well tolerated in this Japanese population, the researchers said. The incidence and nature of adverse events (AEs) were similar across the treatments, as were serious AEs and discontinuations due to AEs. "The combination therapy, as a fixed dose, at 320 plus 9 mcg per day, worked very well compared with the combination of budesonide 400 mcg plus sustained-release theophylline 400 mg/day," Dr. Ohta confirmed. The fixed-dose combination of budesonide and formoterol represents an attractive asthma management option in this patient population, the researchers concluded. Funding for this study was provided by AstraZeneca.
[Presentation title: Efficacy and Safety of Budesonide/ Formoterol Compared With Budesonide and Theophylline in Japanese Adult Patients With Asthma. Abstract P3626]
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