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Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patientsWilliam W. Busse, FAAAAI, MD, Shailen R. Shah, MD, Laura Somerville, MD, PhD, Bhash Parasuraman, PhD, Paula Martin, MS, and Mitchell Goldman, MD, PhD This study offers a direct comparison of maintenance therapy for moderate to severe asthma with the adjustable-dose budesonide/formoterol metered-dose inhaler (MDI) versus the fixed-dose budesonide/formoterol metered-dose inhaler (MDI) and the fixed-dose fluticasone propionate/salmeterol dry powder inhaler (DPI). The adjustable dosing strategy allowed the patient to change the budesonide/formoterol MDI from 2 inhalations twice daily to 2 inhalations once daily or 4 inhalations twice daily. The doses of budesonide/formoterol MDI and fluticasone propionate/salmeterol DPI used in this study follow the recommended dosing regimens for patients with moderate- to-severe asthma. In this study, adjustable-dose budesonide/ formoterol showed no differences in asthma control or tolerability versus fixed-dose fluticasone propionate/salmeterol. The adjustable-dose budesonide/formoterol MDI group did, however, require significantly less study medication versus the fixed-dose budesonide/formoterol MDI. Studies such as those reported in this paper allow for a head-to-head evaluation and, as a consequence, with comparative treatment, to evaluate the effectiveness of adjustable dosing with the budesonide-formoterol combination. However, to compare the results of this study with other efforts, it is first important to understand and appreciate the study design, which varies from protocol to protocol, making direct comparison somewhat limited. In this study, subjects were stabilized on either the fluticasone-salmeterol or budesonide-formoterol combination. Once stabilized, one segment of the budesonide-formoterol combination treated patients was "stepped-down in the use of this combination treatment to once per day." In this sense, a practice very akin to that followed in actual patient care. In previous studies, the adjustable-dose budesonide/formoterol dry powder inhaler (DPI) has demonstrated similar or greater asthma control with less inhaled corticosteroid compared with the fixed-dose budesonide/formoterol DPI.. Past studies, though, have used different strategies for stepping therapy up and down. In the present study, less stringent criteria for step-down dosing and more stringent criteria for step-up dosing were used. In a study by FitzGerald et al, the step-down dose of budesonide/formoterol was lower compared with the present study, which might explain its reduced performance. The data gathered concerning this more flexible dosing schedule does provide some insight into asthma control in patients using budesonide/formoterol pMDI who may not be fully adherent and may reduce their prescribed daily dose by half. Identification of that population of patients is not possible, though, without empirical testing. |
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© 1996-2008 · All Rights Reserved · American Academy of Allergy Asthma & Immunology |
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