Beclomethasone/formoterol in the management of COPD: A randomised controlled trial

被引：85

作者：

Calverley, P. M. A. ^{[1
]}

Kuna, P. ^{[2
]}

Monso, E. ^{[3
,4
]}

Costantini, M. ^{[5
]}

Petruzzelli, S. ^{[5
]}

Sergio, F. ^{[5
]}

Varoli, G. ^{[5
]}

Papi, A. ^{[6
]}

Brusasco, V. ^{[7
]}

机构：

[1] Aintree Univ Hosp NHS Fdn Trust, Dept Med, Pulm & Rehabil Res Grp, Liverpool L9 7AL, Merseyside, England

[2] Med Univ Lodz, Barlicki Univ Hosp, Dept Internal Med Asthma & Allergy, PL-90153 Lodz, Poland

[3] Hosp Badalona Germans Trias & Pujol, CS Parc Tauli, Badalona 08916, Spain

[4] CibeRes Ciber Enfermedades Resp, Badalona 08916, Spain

[5] Chiesi Farmaceut SpA, I-43100 Parma, Italy

[6] Univ Ferrara, Clin Pneumol, I-44121 Ferrara, Italy

[7] Univ Genoa, Dipartimento Med Interna, I-16132 Genoa, Italy

来源：

RESPIRATORY MEDICINE | 2010年 / 104卷 / 12期

关键词：

Chronic obstructive airways disease; COPD; Inhaled corticosteroid; Long acting beta 2 agonist; Lung function; Exacerbations; OBSTRUCTIVE PULMONARY-DISEASE; LUNG-FUNCTION; FIXED COMBINATION; SEVERE ASTHMA; SMALL AIRWAYS; EXACERBATIONS; BUDESONIDE/FORMOTEROL; FLUTICASONE; BUDESONIDE; PROPIONATE;

D O I：

10.1016/j.rmed.2010.09.008

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Objectives To evaluate the effect of beclomethasone/formoterol versus budesonide/formoterol (non inferiority) and versus formoterol (superiority) in patients with severe stable chronic obstructive pulmonary disease (COPD) Methods A double blind, double dummy, randomised, active controlled, parallel group study After 4 weeks run in with ipratropium/salbutamol (40/200 mu g, three times daily) patients were randomised to receive beclomethasone/formoterol (200/12 mu g pressurised metered dose inhaler), budesonide/formoterol (400/12 mu g dry powder inhaler) or formoterol (12 mu g dry powder inhaler) twice daily for 48 weeks Co primary efficacy variables were change from baseline to 48 weeks in pre dose morning forced expiratory volume in 1 s (FEV(1)) and mean rate of COPD exacerbations Results Of 718 patients randomised, 703 (232 beclomethasone/formoterol, 238 budesonide/formoterol, 233 formoterol) were in the ITT analysis Improvement in pre dose morning FEV(1) was 0 077 L, 0 080 L and 0 026 L for beclomethasone/formoterol, budesonide/formoterol and formoterol respectively (LS mean from the ANCOVA model) Beclomethasone/formoterol was not inferior to budesonide/formoterol (95% CI of the difference -0 052, 0 048) and superior to formoterol (p = 0 046) The overall rate of COPD exacerbations/patient/year was similar and not statistically significantly different among treatments (beclomethasone/formoterol 0 414, budesonide/formoterol 0 423 and formoterol 0 431) Quality of life and COPD symptoms improved in all groups and use of rescue medication decreased Safety profiles were as expected and treatments well tolerated Conclusions Beclomethasone/formoterol (400/24 mu g) treatment for 48 weeks improved pulmonary function, reduced symptoms compared to formoterol, was safe and well tolerated in patients with severe stable COPD Neither of the long acting beta 2 agonist/inhaled corticosteroid combinations affected the low exacerbation rate seen in this population (C) 2010 Published by Elsevier Ltd

引用

页码：1858 / 1868

页数：11

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