Study Results

• What We Learned:

• Primary Findings:

  Effectiveness:

  This open-label study enrolled 553 CF patients (Age >=6) to evaluate the safety, efficacy and convenience of TIP™ vs TOBI® for treating Pseudomonas aeruginosa (Pa) infection. Patients were randomized to 3 cycles of 28 days on/28 days off either TIP (112 mg BID) or TOBI (300mg BID). Increases in FEV1% predicted from baseline to Day 28 of Cycle 3 were similar between groups.

   

  Mean reduction in sputum PA density on Day 28 of Cycle 3 and the number of patients hospitalized for respiratory-related events were also similar between groups. The proportion of patients requiring new antipseudomonal antibiotics was significantly higher with TIP than TIS. Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction as determined by the modified patient self-reported Treatment Satisfaction Questionnaire for Medication (TSQM).

  Safety:

  Adverse events were similar in both groups.

• Citation:

  J Cyst Fibros 2011;10(1):54-61

For current information about the overall development status of this drug, please check the Drug Development Pipeline.