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Anti-Infective Completed with Results

PALS: Aztreonam Inhalation Solution (AZLI) Safety Study in Children with CF and Chronic Pseudomonas Aeruginosa (Gilead - GS-US-205-0160)

This open-label study looked at the safety of Aztreonam Inhalation Solution (Cayston®) given three times daily for three 28-day on/28-day off cycles in children with cystic fibrosis and chronic Pseudomonas aeruginosa (PA) infection in the lower airways.

 

Eligibility

  • Age:

    Less than 13 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:

    This study looked at the safety of Aztreonam Inhalation Solution and concluded the it was generally well-tolerated.

  • Primary Findings:

    Effectiveness:

    This study was conducted between December 29, 2011 and April 3, 2013. In this study 61 children (younger than 13 years) were enrolled and treated with three cycles of Aztreonam for Inhalation Solution. The primary efficacy endpoint was the percentage of participants who discontinued Aztreonam for Inhalation Solution for reasons of safety and tolerability. Of the 61 participants treated, 2 withdrew from the study. The reasons for withdrawal were not related to safety or tolerability, thus this study met its primary endpoint.

     

    Additional outcomes evaluated were change in lung function, CFQ-R Respiratory Symptoms Scale (RSS) Score, Pseudomonas aeruginosa sputum density and use of additional anti-pseudomonal antibiotics. These data were provided by ClinicalTrials.gov and have not been peer-reviewed.

    Safety:

  • 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

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    6 months

  • Number of Study Visits:

    8

Additional Information

  • Phase: ?more info

    Phase Four/Post-Approval

  • Study Sponsor: ?more info

    Gilead

  • Study Drugs:

    Aztreonam (Cayston®)

Eligibility

  • Age:

    Less than 13 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

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

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