Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patients

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:121

Article

Busse, William W.¹  Shah, Shailen R.²  Somerville, Laura³  Parasuraman, Bhash⁴  Martin, Paula⁴  Goldman, Mitchell⁴ 

[1] Univ Wisconsin Hosp & Clin, Madison, WI 53792 USA

[2] Allergy & Asthma Consultants, Collegeville, PA USA

[3] Houston Allergy & Asthma Associates, Houston, TX USA

[4] AstraZeneca, Wilmington, NC USA

关键词: budesonide;    formoterol;    fluticasone propionate;    salmeterol;    adjustable dosing;    asthma;   

DOI  :  10.1016/j.jaci.2008.03.019

来源: Elsevier

【 摘 要 】

Background: 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. Objective: We sought to evaluate the efficacy, tolerability, and resource use of maintenance therapy with the adjustable-dose budesonide/formoterol pressurized metered-dose inhaler versus the fixed-dose budesonide/formoterol pressurized metered-dose inhaler and the fixed-dose fluticasone propionate/salmeterol DPI. Methods: This was a randomized, open-label, multicenter study of patients (N = 1225) 12 years and older with moderate-to-severe persistent asthma. After 10 to 14 days of current therapy, patients were randomized 2:1 to fixed-dose budesonide/formoterol (160/4.5 mu g X 2 inhalations [320/9 mu g] twice daily) or fixed-dose fluticasone propionate/salmeterol (250/50 mu g x 1 inhalation twice daily) for 1 month (treatment period 1), after which, the fixed-dose fluticasone propionate/salmeterol group continued therapy and the fixed-dose budesonide/formoterol group was randomized 1:1 to fixed-dose budesonide/formoterol or adjustable-dose budesonide/formoterol (adjustable from 2 inhalations [320/9 mu g] twice daily to 2 inhalations [320/9 mu g] once daily or 4 inhalations [640/18 mu g] twice daily) for 6 months (treatment period 2). Results: There were no significant between-group differences in asthma exacerbations (primary variable), asthma symptoms, or lung function during the 7-month treatment period. Less study drug (inhalations per day, P<.001) was used with adjustable-dose versus fixed-dose budesonide/formoterol. All treatments were well tolerated. Conclusions: Adjustable-dose and fixed-dose budesonide/formoterol showed no differences in asthma control or tolerability versus fixed-dose fluticasone propionate/salmeterol.

【 授权许可】

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