Wadbo M, Löfdahl C G, Larsson K, Skoogh B E, Tornling G, Arweström E, Bengtsson T, Ström K
Dept of Respiratory Medicine in Malmö General University Hospital, Malmö, Sweden.
Eur Respir J. 2002 Nov;20(5):1138-46. doi: 10.1183/09031936.02.00301702.
The aim of this study was to compare the effects of formoterol, ipratropium bromide and a placebo on walking distance, lung function, symptoms and quality of life (QoL) in chronic obstructive pulmonary disease (COPD) patients. A total of 183 patients (mean age 64 yrs, 86 female) with moderate-to-severe nonreversible COPD participated in this randomised, double-blind, parallel-group study. After a 2-week placebo run-in, patients were randomised to formoterol Turbuhaler 18 microg b.i.d. (delivered dose), ipratropium bromide 80 microg t.i.d. via a pressurised metered dose inhaler, or placebo for 12 weeks. Inhaled short-acting beta2-agonists were allowed as relief medication and inhaled glucocorticosteroids were allowed at a constant dose. The primary variable was walking distance in the shuttle walking test (SWT). Baseline mean SWT distance was 325 m, mean forced expiratory volume in one second (FEV1) was 40% predicted. Clinically significant improvements in SWT (>30 m) were seen in 41, 38 and 30% of formoterol, ipratropium and placebo patients, respectively (not significant). Mean increases from run-in were 19, 17 and 5 m in the formoterol, ipratropium and placebo groups, respectively. Both active treatments significantly improved FEV1, forced vital capacity, peak expiratory flow and daytime dyspnoea score compared with placebo. Formoterol reduced relief medication use compared with placebo. Neither active treatment improved QoL. Formoterol and ipratropium improved airway function and symptoms, without significant improvements in the shuttle walking test.
本研究旨在比较福莫特罗、异丙托溴铵和安慰剂对慢性阻塞性肺疾病（COPD）患者步行距离、肺功能、症状及生活质量（QoL）的影响。共有183例中重度不可逆COPD患者（平均年龄64岁，女性86例）参与了这项随机、双盲、平行组研究。经过2周的安慰剂导入期后，患者被随机分为三组，分别接受福莫特罗都保18μg，每日两次（递送剂量）、通过压力定量吸入器吸入异丙托溴铵80μg，每日三次，或接受安慰剂治疗12周。允许使用吸入性短效β2受体激动剂作为缓解药物，并允许以恒定剂量使用吸入性糖皮质激素。主要变量是往返步行试验（SWT）中的步行距离。基线时SWT平均距离为325米，一秒用力呼气容积（FEV1）平均为预测值的40%。福莫特罗、异丙托溴铵和安慰剂组中分别有41%、38%和30%的患者在SWT中出现了具有临床意义的改善（>30米）（无显著性差异）。福莫特罗组、异丙托溴铵组和安慰剂组从导入期开始的平均增加量分别为19米、17米和5米。与安慰剂相比，两种活性治疗均显著改善了FEV1、用力肺活量、呼气峰值流速和日间呼吸困难评分。与安慰剂相比，福莫特罗减少了缓解药物的使用。两种活性治疗均未改善生活质量。福莫特罗和异丙托溴铵改善了气道功能和症状，但在往返步行试验中无显著改善。
