College of Medicine, Orlando Regional Campus, Florida State University, Orlando, Florida.
Respir Care. 2014 Mar;59(3):388-98. doi: 10.4187/respcare.02264. Epub 2013 Aug 27.
Tobramycin powder for inhalation (TIP) is a drug-device combination designed to reduce treatment time and improve ease of use compared with tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients. However, the ability of patients to use dry powder inhalers, and the efficacy of the treatments, may vary by age.
The "Establish a New Gold Standard for Efficacy and Safety With Tobramycin in Cystic Fibrosis" (EAGER) trial was a randomized, 24-week, multicenter, open-label, parallel-group study designed to evaluate the safety of TIP versus TIS in 553 subjects, ages ≥ 6 years, with CF and P. aeruginosa infection. The main efficacy end point was percent-of-predicted FEV1 at week 20 (end of third cycle of treatment). A post hoc analysis was undertaken in 517 subjects who took ≥ 1 dose of study medication, to evaluate the relative efficacy and safety of TIP and TIS by age group: ≥ 6 to < 13 y (children, n = 46); ≥ 13 to < 20 y (adolescents, n = 114); and ≥ 20 y (adults, n = 357).
Improvements in percent-of-predicted FEV1 from baseline to end of cycle 3 were greatest in the children for both TIP and TIS. The treatment differences (TIP - TIS) were 4.7% (85% CI -1.2 to 10.6), 3.7% (85% CI -0.1 to 7.5), and -0.8% (85% CI -3.1 to 1.5) in children, adolescents, and adults, respectively. Sputum P. aeruginosa density decreased from baseline with both treatments, with comparable treatment differences across the age groups after 3 cycles: children -0.93 (85% CI -2.4 to 0.5), adolescents -0.17 (85% CI -1.2 to 0.8), and adults -0.89 (85% CI -1.3 to -0.4). Overall, subject satisfaction scores were greater in all subjects with TIP, irrespective of age group. With the exception of cough and dysphonia, the safety profile of TIP was comparable to TIS, irrespective of age.
TIP is comparable to TIS in efficacy outcomes and safety profile but had greater patient satisfaction in all the age groups.
妥布霉素吸入粉（TIP）是一种药物-器械组合，与妥布霉素吸入溶液（TIS）相比，旨在减少囊性纤维化（CF）患者的治疗时间并提高使用便利性。然而，患者使用干粉吸入器的能力以及治疗的效果可能因年龄而异。
“用妥布霉素在囊性纤维化中建立新的疗效和安全性金标准”（EAGER）试验是一项随机、24 周、多中心、开放性、平行组研究，旨在评估 TIP 与 TIS 在 553 例年龄≥6 岁、患有 CF 和铜绿假单胞菌感染的受试者中的安全性。主要疗效终点为第 20 周（治疗第三周期结束时）预测 FEV1 的百分比。对接受≥1 次研究药物治疗的 517 例受试者进行了事后分析，按年龄组评估 TIP 和 TIS 的相对疗效和安全性：≥6 至<13 岁（儿童，n=46）；≥13 至<20 岁（青少年，n=114）；和≥20 岁（成人，n=357）。
在 TIP 和 TIS 中，从基线到第 3 个周期结束时，预测 FEV1 的百分比增加最大的是儿童。在儿童、青少年和成年人中，治疗差异（TIP-TIS）分别为 4.7%（85%CI-1.2 至 10.6）、3.7%（85%CI0.1 至 7.5）和-0.8%（85%CI-3.1 至 1.5）。两组治疗后 3 个周期痰液铜绿假单胞菌密度均从基线下降，各年龄组治疗差异相当：儿童-0.93（85%CI-2.4 至 0.5）、青少年-0.17（85%CI-1.2 至 0.8）和成年人-0.89（85%CI-1.3 至-0.4）。总体而言，无论年龄组如何，所有接受 TIP 治疗的受试者的满意度评分均较高。除咳嗽和发音困难外，TIP 的安全性与 TIS 相当，与年龄无关。
TIP 在疗效和安全性方面与 TIS 相当，但在所有年龄组中都有更高的患者满意度。
