Tinkelman D G, Bleecker E R, Ramsdell J, Ekholm B P, Klinger N M, Colice G L, Slade H B
Department of Medicine, University of Maryland, Baltimore, USA.
Chest. 1998 Feb;113(2):290-6. doi: 10.1378/chest.113.2.290.
As a secondary objective to a long-term study evaluating the bronchodilator effectiveness of Proventil HFA (albuterol), to assess the safety of Proventil HFA, Ventolin, and hydrofluoroalkane 134a (HFA-134a) placebo over 12 weeks of regular dosing.
Randomized, double-blind, double-dummy parallel group, placebo-controlled, multicenter trial of asthmatics requiring inhaled beta-adrenergic bronchodilators for symptom control.
Treatment with Proventil HFA, Ventolin, or HFA-134a placebo, qid, for 12 weeks.
Adverse events were reviewed at biweekly clinic visits. Between clinic visits, patients recorded morning and evening peak expiratory flow (PEF), asthma symptom and nighttime asthma sleep disturbance scores, and use of rescue beta-adrenergic bronchodilator on diary cards daily. Investigators provided a global assessment of asthma control at weeks 0, 4, 8, and 12. Vital signs were recorded over 6 h after dosing with study drug at weeks 0, 4, 8, and 12. Standard laboratory tests, CBC count, serum chemistries, and urinalysis were obtained at study start and end.
Adverse event reporting rates were similar for the three treatment groups. The morning PEF tended to be lower for the Proventil HFA and Ventolin groups than the HFA-134a placebo group, but the evening PEF tended to be higher for the active treatment groups. Daytime asthma symptom scores tended to be lower (better) with active treatment than placebo, but nighttime asthma sleep disturbance scores were similar for all three treatment groups. Use of Ventolin Rotacaps as rescue medication was significantly greater for the HFA-134a placebo group than the Proventil HFA and Ventolin groups. Diary card data did not change within groups over time. Investigator global assessments of asthma scores clustered between fair and good for all three treatment groups throughout the study. Changes in heart rate and BP were small after dosing with study drug and tended to be similar for the active treatments and HFA-134a placebo groups. No clinically meaningful changes in results of standard laboratory tests were found in any treatment group during this study.
Proventil HFA had a similar safety profile as Ventolin during regular use. A dosage of 16 puffs per day of propellant HFA-134a was well tolerated by asthmatics. Regular use of either Proventil HFA or Ventolin did not cause asthma control to deteriorate.
作为一项评估喘乐宁HFA（沙丁胺醇）支气管扩张剂疗效的长期研究的次要目标，评估喘乐宁HFA、万托林和氢氟烷烃134a（HFA - 134a）安慰剂在12周常规给药期间的安全性。
针对需要吸入β - 肾上腺素能支气管扩张剂来控制症状的哮喘患者进行的随机、双盲、双模拟平行组、安慰剂对照、多中心试验。
使用喘乐宁HFA、万托林或HFA - 134a安慰剂进行治疗，每日4次，持续12周。
在每两周一次的门诊就诊时复查不良事件。在门诊就诊期间，患者每天在日记卡上记录早晚的呼气峰值流速（PEF）、哮喘症状及夜间哮喘睡眠障碍评分，以及急救β - 肾上腺素能支气管扩张剂的使用情况。研究人员在第0、4、8和12周对哮喘控制情况进行整体评估。在第0、4、8和12周，在给予研究药物后6小时记录生命体征。在研究开始和结束时进行标准实验室检查、全血细胞计数、血清化学检查和尿液分析。
三个治疗组的不良事件报告率相似。喘乐宁HFA组和万托林组的早晨PEF往往低于HFA - 134a安慰剂组，但活性治疗组的晚上PEF往往较高。活性治疗组的白天哮喘症状评分往往低于（优于）安慰剂组，但三个治疗组的夜间哮喘睡眠障碍评分相似。HFA - 134a安慰剂组作为急救药物使用万托林旋帽气雾剂的情况显著多于喘乐宁HFA组和万托林组。日记卡数据在组内随时间未发生变化。在整个研究过程中，三个治疗组的研究人员对哮喘评分的整体评估集中在一般和良好之间。给予研究药物后心率和血压的变化较小，活性治疗组和HFA - 134a安慰剂组的变化趋势相似。在本研究期间，任何治疗组的标准实验室检查结果均未发现有临床意义的变化。
喘乐宁HFA在常规使用时的安全性与万托林相似。哮喘患者对每天16揿的推进剂HFA - 134a耐受性良好。常规使用喘乐宁HFA或万托林均未导致哮喘控制恶化。
