CLINICAL TRIAL: SAFETY OF TOBRAMYCIN INHALATION POWDER COMPARED TO TOBI IN CYST

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 本研究（TIP 003）是一项随机、开放标签、活性对照、平行组试验。合格受试者将以3：2的比例随机分配至TIP或TOBI组。治疗将持续28天，随后停药28天，共3个周期。 主要目的是在囊性纤维化（CF）受试者中评价通过T-326吸入器递送的妥布霉素吸入粉（TIP）每日两次（BID）给药方案与通过PARI LC PLUS喷射雾化器和DeVilbiss PulmoAide压缩器或适当替代品递送的妥布霉素吸入溶液（TOBI）的安全性。 次要目的是：（a）评估TIP与TOBI相比的功效，如通过从基线到第3周期给药结束时1秒用力呼气量（FEV1%预测值）的相对变化所测量的;和（B）通过施用药物治疗满意度问卷（TSQM）来评估受试者报告的治疗满意度。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study (TIP003) is a randomized, open-label, active-controlled, parallel-arm trial. Eligible subjects will be randomized to TIP or TOBI at a 3:2 ratio. Treatment will be administered for 28 days, followed by 28 days off therapy, for 3 cycles. The primary objective is to evaluate the safety in cystic fibrosis (CF) subjects of a twice-daily (BID) dosing regimen of Tobramycin Inhalation Powder (TIP) delivered by the T-326 Inhaler as compared to Tobramycin Solution for Inhalation (TOBI) delivered with the PARI LC PLUS Jet Nebulizer and DeVilbiss PulmoAide compressor or a suitable alternative. The secondary objectives are: (a) to assess the efficacy of TIP as compared to TOBI, as measured by the relative change in forced expiratory volume at 1 second (FEV1 % predicted) from baseline to the end of cycle 3 dosing; and (b) to assess subject-reported treatment satisfaction by administering the Treatment Satisfaction Questionnaire for Medication (TSQM).