Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma

被引:503
作者
O'Byrne, PM
Bisgaard, H
Godard, PP
Pistolesi, M
Palmqvist, M
Zhu, YJ
Ekström, T
Bateman, ED
机构
[1] St Josephs Hosp, Firestone Inst Resp Hlth, Hamilton, ON L8N 4A6, Canada
[2] Univ Hosp Copenhagen, COPSAC Clin Res Unit, Gentofte, Denmark
[3] Hop Arnaud Villeneuve, Serv Malad Resp & Bronchomotricite, Montpellier, France
[4] Univ Florence, Dept Crit Care, Sect Resp Med, Florence, Italy
[5] Sahlgrens Univ Hosp, Dept Resp Med & Allergol, S-41345 Gothenburg, Sweden
[6] Beijing Union Med Coll Hosp, Resp Dept, Beijing, Peoples R China
[7] AstraZeneca R&D, Lund, Sweden
[8] Univ Cape Town, ZA-7925 Cape Town, South Africa
关键词
inhaled corticosteroids; long-acting beta(2)-agonists; management; single inhaler;
D O I
10.1164/rccm.200407-884OC
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Asthma control is improved by combining inhaled corticosteroids with long-acting beta(2)-agonists. However, fluctuating asthma control still occurs. We hypothesized that in patients receiving low maintenance dose budesonide/formoterol (bud/form), replacing short-acting beta(2)-agonist (SABA) reliever with as-needed bud/form would provide rapid symptom relief and simultaneous adjustment in anti-inflammatory therapy, thereby reducing exacerbations. In this double-blind, randomized, parallel-group study, 2,760 patients with asthma aged 4-80 years (FEV1 60-100% predicted) received either terbutaline 0.4 mg as SABA with bud/form 80/4.5 mug twice a day (bud/form + SABA) or bud 320 mug twice a day (bud + SABA) or bud/form 80/4.5 mug twice a day with 80/4.5 mug as-needed (bud/form maintenance + relief). Children used a once-nocte maintenance dose. Bud/form maintenance + relief prolonged time to first severe exacerbation (p < 0.001; primary endpoint), resulting in a 45-47% lower exacerbation risk versus bud/form + SABA (hazard ratio, 0.55; 95% confidence interval, 0.44, 0.67) or bud + SABA (hazard ratio, 0.53; 95% confidence interval 0.43, 0.65). Bud/form maintenance + relief also prolonged the time to the first, second, and third exacerbation requiring medical intervention (p < 0.001), reduced severe exacerbation rate, and improved symptoms, awakenings, and lung function compared with both fixed dosing regimens.
引用
收藏
页码:129 / 136
页数:8
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