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Observational Completed with Results

TOBI Podhaler Usability Study (Novartis CTBM100C2412)

This study evaluated how well people were able to understand and follow the TOBI Podhaler® instructions for use to achieve appropriate dosing. Study participants were asked to inhale the contents of placebo capsules through the Podhaler device by following the instructions for use. Researchers evaluated if participants following the instructions demonstrated safe and effective use of the Podhaler device.

 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25% or greater

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

Other Primary Eligibility Criteria

Previous experience with the Podhaler device.

Study Results

  • What We Learned:

    This study showed that most participants can understand and follow the TOBI Podhaler instructions for use and can achieve safe and appropriate dosing.

  • Primary Findings:

    Effectiveness:

    Safety:

    This study was conducted between August 2014 and February 2015 and enrolled 45 participants. All participants completed the study. The study found that most participants (78%; n=35/45) successfully followed the instructions to achieve safe and effective use of the device. The remaining 10 participants did not fully understand the instructions and therefore did not completely inhale the contents of the capsules, which resulted in an ineffective dose. The sponsor is considering modifying the instruction sheet to address these issues. No participants discontinued the study due to an adverse event. These data were provided by the Novartis Clinical Trial Results Website and have not been peer-reviewed.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

    Observational

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    1 months

  • Number of Study Visits:

    2

Additional Information

  • Phase: ?more info

    Phase Four/Post-Approval

  • Study Sponsor: ?more info

    Novartis

  • Study Drugs:

    N/A

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25% or greater

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

Other Primary Eligibility Criteria

Previous experience with the Podhaler device.

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