Study Results

• What We Learned:

  This study looked at the long term safety of tobramycin inhalation powder (TIP) and found that the adverse event frequency and profile were similar to the known TIP safety profile.

• Primary Findings:

  Effectiveness:

  This study was conducted between January 16, 2012 and January 13, 2014. The study enrolled 157 participants and all received tobramycin inhalation powder (TIP). Of the 157 participants, 96 completed the study and 61 discontinued. Primary reasons for discontinuation included adverse events (18.5%) and the participant’s decision to withdraw consent (10.8%). The primary objective of this study was to assess the safety of tobramycin inhalation powder (TIP) over 6 cycles of treatment.

   

  Safety:

  The adverse event frequency and profile were similar to the known TIP safety profile.

  Of the 96 participants who completed this study, 45 elected to participate in an additional one year extension. All 45 completed the extension and no new safety signals or increases in the frequency of adverse events were identified.

  These data were provided by the Novartis Clinical Trial Results Website and have not been peer-reviewed.

• Citation:

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