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Anti-Infective Completed with Results

Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered Twice a Day Cycled (NOVARTIS CTBM100CUS03)

This open-label study tested the effectiveness and safety of two different dose regimens of Tobramycin Inhalation Powder (TIP) for the treatment of Pseudomonas aeruginosa. Participants were randomized to receive either TIP once a day continuously or to receive TIP twice daily intermittently (28 days on-drug followed by 28 days off-drug) for a total of 24 weeks.

 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 80%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2) Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration Use of loop diuretics within 7 days prior to study drug administration Administration of any investigational drug within 30 days prior to enrollment or 5 halflives, whichever is longer

Study Results

  • What We Learned:

    This study was not completed due to an inability to recruit participants.

  • Primary Findings:

    Effectiveness:

    This study was conducted between January 2014 and December 2014. The study enrolled 16 participants into each treatment group (continuous versus intermittent TIP). However, the study was prematurely stopped on November 14, 2014 because recruiting participants became a limitation. Only 31 participants were dosed and only 5 participants completed the planned 24 week study. The primary efficacy endpoint was to determine the difference in lung function (absolute FEV1% predicted) between tobramycin inhalation powder (TIP) taken once daily continuously versus TIP twice daily in 28 day on/off cycles. Changes over time in lung function and difference in lung function between the two treatment groups could not be adequately assessed.

     

    Additional secondary objectives were not evaluated due to the early termination of the study.

    Safety:

    No new safety signals were identified in this study. These data were provided by the Novartis Clinical Trial Results Website and have not been peer-reviewed.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.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    24 weeks

  • Number of Study Visits:

    9

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 80%

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2) Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration Use of loop diuretics within 7 days prior to study drug administration Administration of any investigational drug within 30 days prior to enrollment or 5 halflives, whichever is longer

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