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Denufosol in People with CF ages 2 - 4 years (Inspire 08-116)

The purpose of this study was to look at the safety and tolerability of denufosol aerosolized three times a day in pediatric CF patients 2 to 4 years of age.

Participants were randomized to receive either denufosol or placebo for 7 to 10 days.

Eligibility

  • Age:

    2 Years to 4 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

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

Study Results

  • What We Learned:

    Study results show that there were no serious adverse events associated with denufosol. The most commonly reported adverse event was coughing.

  • Primary Findings:

    Effectiveness:

    This study was conducted between August 2010 and January 2011. A total of 24 children participated in the study. The effectiveness of denufosol was not evaluated during this short-term study.

     

    Safety:

    Denufosol was well tolerated. No subjects met pre-defined intolerability criteria as evaluated at the 2 study visits. The most commonly reported adverse event was coughing.

    The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2011). These data may be preliminary and have not been peer-reviewed.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

    Yes

  • Length of Participation:

    10 days

  • Number of Study Visits:

    2

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Inspire

  • Study Drugs:

    Denufosol

Eligibility

  • Age:

    2 Years to 4 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

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

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