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Anti-Infective Closed to Enrollment

Inhaled Levofloxacin (MP-376) pediatric safety study (MPEX 206)

This study looked at the safety and tolerability of MP-376 Inhalation Solution, as well as how the body processes the drug. MP-376 is a novel formulation of the drug levofloxacin that has been optimized for aerosol delivery.

This study was open-label, meaning that all study participants received the study drug. MP-376 was tested at two different doses based on the participant’s weight. Researchers investigated how the drug works in the body by studying its profile in the bloodstream and in sputum. They also tracked lung function and looked for safety signals.

Eligibility

  • Age:

    6 Years to 16 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 95%

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

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    35 days

  • Number of Study Visits:

    6

Additional Information

Study Sites

  • Closed to Enrollment

    Alabama

    CF Center University of South Alabama (Mobile, AL), Mobile, AL 36640

  • Closed to Enrollment

    California

    Rady Children's Hospital and Health Center at the University of California San Diego, San Diego, CA 92123

  • Closed to Enrollment

    Florida

    The Nemours Children's Clinic - Orlando, Orlando, FL 32827

  • Closed to Enrollment

    Michigan

    Children's Hospital of Michigan, Detroit, MI 48201

  • Closed to Enrollment

    Missouri

    Children's Mercy Kansas City, Kansas City, MO 64108

  • Closed to Enrollment

    Ohio

    Children's Hospital Medical Center of Akron, Akron, OH 44308

Eligibility

  • Age:

    6 Years to 16 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 95%

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

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