Ringdal N, Derom E, Wåhlin-Boll E, Pauwels R
Medical Department, Fylkessykhuset i Molde, Norway.
Respir Med. 1998 Aug;92(8):1017-21. doi: 10.1016/s0954-6111(98)90348-1.
The aim of the study was to investigate the time of onset and the duration of the bronchodilating effect of different doses of formoterol administered via Turbuhaler in patients with moderate asthma. Thirty-one patients (five women) with a mean forced expiratory volume in 1 s (FEV1) of 1.97 +/- 0.54 1 and a mean reversibility of 31 +/- 14% of baseline were included in this double-blind, randomized, placebo-controlled and cross-over study. The patients inhaled single doses of placebo, i.e. 6, 12, 24, or 48 micrograms formoterol fumarate, on 5 separate days. Serial measurements of specific airways conductance (SGAW) and FEV1 were performed at regular time intervals for 12 h. The majority of the patients had at least a 50% increase in SGAW within 1-4 min after administration of all active treatments. The maximum increase in FEV1 over placebo was dose-dependent: 12% (6 micrograms), 18% (12 micrograms), 19% (24 micrograms), and 26% (48 micrograms) (P < 0.001). Twelve hours after administration of 6, 12, 24, and 48 micrograms formoterol, the mean increase in FEV1 was still 7%, 15%, 18%, and 27%, respectively, above the value following placebo. Headache was the most frequently reported adverse event in all treatments including placebo. After inhalation of 48 micrograms, three patients experienced mild tremor lasting for less than 1 h; likewise, one patient experienced the same event for 3 h after placebo. Formoterol administered via Turbuhaler10 gave a rapid and dose-related bronchodilating effect lasting for 12 h and was well tolerated.
本研究旨在调查中度哮喘患者经都保装置吸入不同剂量福莫特罗后的起效时间及支气管舒张作用持续时间。本双盲、随机、安慰剂对照、交叉试验纳入了31例患者（5例女性），其1秒用力呼气容积（FEV1）均值为1.97±0.54升，平均可逆性为基线值的31±14%。患者在5个不同日期分别吸入单剂量安慰剂、即6、12、24或48微克富马酸福莫特罗。在12小时内定期测量比气道传导率（SGAW）和FEV1。在给予所有活性治疗后1 - 4分钟内，大多数患者的SGAW至少增加50%。FEV1相对于安慰剂的最大增加呈剂量依赖性：12%（6微克）、18%（12微克）、19%（24微克）和26%（48微克）（P < 0.001）。在给予6、12、24和48微克福莫特罗12小时后，FEV1的平均增加仍分别比安慰剂后的数值高7%、15%、18%和27%。头痛是包括安慰剂在内的所有治疗中最常报告的不良事件。吸入48微克后，3例患者出现持续不到1小时的轻度震颤；同样，1例患者在吸入安慰剂后3小时出现相同事件。经都保装置吸入的福莫特罗产生快速且与剂量相关的支气管舒张作用，持续12小时，耐受性良好。
