Koser Andras, Westerman Jan, Sharma Sanjay, Emmett Amanda, Crater Glenn D
Greenville Pharmaceutical Research, Greenville, SC 864-770-0890, USA.
Open Respir Med J. 2010 Oct 21;4:86-91. doi: 10.2174/1874306401004010086.
To provide information on the efficacy and safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg (FSC MDI) and its comparable dose of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg (FSC DISKUS) in patients with COPD.
This multicenter, randomized, double-blind, 12 week study was designed to evaluate FSC MDI treatment responses as compared with FSC DISKUS. The primary comparison of interest was non-inferiority between the FSC MDI treatment group and the FSC DISKUS treatment group assessed in terms of 2-hour post-dose FEV(1) change from baseline at endpoint. The non-inferiority criterion bound was 75mL (lower confidence limit of -75mL).
Male or female aged ≥ 40, post-bronchodilator FEV(1) ≤ 70% predicted normal, FEV(1)/FVC ≤ 70% and ≥ 10 pack years smoking history. Adverse events were recorded by patients throughout the study on daily diary cards. Adverse events were collected in eCRFs at all clinic visits and during a final follow-up phone call.
Patients (N=247) were randomized to FSC MDI (FEV(1)% 49.3 ± 12.3, FEV(1)/FVC 50.5 ± 10.0) and FSC DISKUS (FEV(1)% 48.4 ± 11.0, FEV(1)/FVC 50.3 ± 10.3). From an ANCOVA model the least squares (LS) mean difference (FSC MDI- FSC DISKUS) for the 2-hour post dose FEV(1) at endpoint was -2.0mL (95% CI -64mL, 59mL). Pre-dose FEV(1), FVC, PEF, and albuterol use were also similar between the two formulations. The most common adverse events (AE) during treatment were headache (8% and 6% of patients), nasopharyngitis (4% and 6%), cough (3% and 4%), and sinusitis (2% and 5%) for FSC MDI and FSC DISKUS, respectively. Pneumonia was recorded as an AE for 2 (2%) patients in the FSC DISKUS arm.
This is the first study to demonstrate that FSC MDI has a similar efficacy and safety profile to FSC DISKUS in COPD patients.
提供丙酸氟替卡松/沙美特罗氢氟烷134a定量吸入器230/42微克（FSC MDI）及其可比剂量的丙酸氟替卡松/沙美特罗准纳器250/50微克（FSC DISKUS）在慢性阻塞性肺疾病（COPD）患者中的疗效和安全性信息。
这项多中心、随机、双盲、为期12周的研究旨在评估FSC MDI与FSC DISKUS相比的治疗反应。主要感兴趣的比较是FSC MDI治疗组和FSC DISKUS治疗组之间在终点时给药后2小时FEV(1)较基线变化方面的非劣效性。非劣效性标准界限为75毫升（下限置信区间为-75毫升）。
年龄≥40岁的男性或女性，支气管扩张剂使用后FEV(1)≤预测正常值的70%，FEV(1)/FVC≤70%且吸烟史≥10包年。在整个研究过程中，患者通过每日日记卡记录不良事件。在所有门诊就诊时以及最后一次随访电话中，通过电子病例报告表收集不良事件。
患者（N = 247）被随机分为FSC MDI组（FEV(1)% 49.3 ± 12.3，FEV(1)/FVC 50.5 ± 10.0）和FSC DISKUS组（FEV(1)% 48.4 ± 11.0，FEV(1)/FVC 50.3 ± 10.3）。根据协方差分析模型，终点时给药后2小时FEV(1)的最小二乘（LS）均值差异（FSC MDI - FSC DISKUS）为-2.0毫升（95%置信区间-64毫升，59毫升）。两种制剂给药前的FEV(1)、FVC、呼气峰流速（PEF）和沙丁胺醇使用情况也相似。治疗期间最常见的不良事件（AE），FSC MDI组分别为头痛（患者的8%和6%）、鼻咽炎（4%和6%）、咳嗽（3%和4%）以及鼻窦炎（2%和5%），FSC DISKUS组分别为头痛（患者的8%和6%）、鼻咽炎（4%和6%）、咳嗽（3%和4%）以及鼻窦炎（2%和5%）。在FSC DISKUS组中有2名（2%）患者记录有肺炎这一不良事件。
这是第一项证明FSC MDI在COPD患者中具有与FSC DISKUS相似的疗效和安全性的研究。
