1 Department of Research & Development, Clinical PK CV, Bayer AG, Wuppertal, Germany.
2 Department of Clinical Operations, Inamed GmbH, Gauting, Germany.
J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):156-163. doi: 10.1089/jamp.2018.1464. Epub 2019 Mar 8.
As non-cystic fibrosis bronchiectasis (NCFB) progresses, patients suffer irreversible lung damage and deterioration in lung function. This study explored whether inhalational parameters (peak inspiratory flow [PIF, primary endpoint], inspiratory volume and time [secondary endpoints]) represent barriers to complete dosing in patients with poor lung function who are using Ciprofloxacin dry powder for inhalation (DPI) (a drug-device combination of the T-326 inhaler device and a Ciprofloxacin dry powder formulation). This open-label, multicenter study generated inspiratory flow rate data from patients with NCFB using the breath-actuated T-326 dry powder inhaler. These rates were compared against reference values to identify whether patients with all degrees of lung function impairment could generate sufficient flow rates to facilitate adequate drug delivery. Patients attended screening and a second visit 1 - 14 days later. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, and inspiratory capacity were measured via spirometry at both visits. Forty-two patients were screened for inclusion; 33 met eligibility criteria and were stratified into one of three groups based on their FEV1% predicted value (group 1: 25% ≤ FEV1% predicted <45%; group 2: 45% ≤ FEV1% predicted <70%; group 3: FEV1% predicted ≥70%). No significant between-group differences occurred in PIF (mean flow rates 68.21, 66.01, and 65.18 L/min in groups 1, 2, and 3, respectively). Individual minimum PIFs of 46.0-49.0 L/min were observed across groups. These results all exceeded the reference value (minimum PIF 45 L/min for Ciprofloxacin DPI) indicating that regardless of the level of airflow obstruction, patients were capable of achieving sufficient PIFs to aerosolize and inhale Ciprofloxacin dry powder with the T-326 inhaler. Our data indicate that T-326 is suitable for use in the drug-device combination Ciprofloxacin DPI to provide targeted pulmonary delivery in patients with NCFB, including those with significantly impaired lung function.
随着非囊性纤维化性支气管扩张症（NCFB）的进展，患者会遭受不可逆转的肺损伤和肺功能恶化。本研究旨在探讨在使用环丙沙星干粉吸入剂（DPI）（T-326 吸入器和环丙沙星干粉制剂的药物-器械组合）的肺功能较差的患者中，吸入参数（吸气峰流速[PIF，主要终点]、吸气量和时间[次要终点]）是否代表完全给药的障碍。这项开放标签、多中心研究使用呼吸驱动的 T-326 干粉吸入器从 NCFB 患者中生成吸气流量数据。这些速率与参考值进行了比较，以确定所有肺功能受损程度的患者是否能够产生足够的流速来促进药物的充分输送。患者在筛选和第二次就诊之间的 1-14 天进行随访。两次就诊时均通过肺活量计测量一秒用力呼气量（FEV1）、用力肺活量（FVC）、FEV1/FVC 和吸气量。对 42 名患者进行了筛选，其中 33 名符合入选标准，并根据其 FEV1%预计值分为三组：第 1 组：FEV1%预计值 25%≤FEV1%预计值<45%；第 2 组：FEV1%预计值 45%≤FEV1%预计值<70%；第 3 组：FEV1%预计值≥70%。PIF（第 1、2 和 3 组的平均流速分别为 68.21、66.01 和 65.18L/min）在组间无显著差异。在各组中均观察到 46.0-49.0L/min 的个体最小 PIF。这些结果均超过参考值（环丙沙星 DPI 的最小 PIF 为 45L/min），表明无论气流阻塞程度如何，患者都能够达到足够的 PIF 以雾化并吸入 T-326 吸入器中的环丙沙星干粉。我们的数据表明，T-326 适合与环丙沙星 DPI 药物-器械组合一起使用，以在 NCFB 患者中提供靶向肺部给药，包括那些肺功能严重受损的患者。
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