TOBRAMYCIN INHALATION POWDER COMPARED TO TOBI IN CYSTIC FIBROSIS SUBJECTS

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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 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).