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Anti-Infective Completed with Results

Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with P. aeruginosa (AIR-CF1) (CP-AI-007)

The purpose of this study was to evaluate the safety and efficacy of an experimental inhaled antibiotic, Aztreonam, in CF patients who have respiratory infections caused by the Pseudomonas aeruginosa bacteria.

Reducing damage from chronic Pseudomonas aeruginosa lung infections is vital to maintaining best health in people with CF.

Eligibility

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 75%

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

Study Results

  • What We Learned:

  • Primary Findings:

    Effectiveness:

    One hundred and sixty-three patients who were > 6 years of age with moderate to severe lung disease (FEV1 >25% to <75% predicted) were enrolled. The primary outcome measure was change in respiratory symptoms using the CFQ-R Respiratory Score. After 28-days treatment, AZLI improved mean CFQ-R-Respiratory scores(9.7 points, P<0.001) compared with placebo.

     

    Pver the 28-day treatment period, AZLI also improved FEV1 (10.3%, P<0.001), and sputum PA density (-1.453 log10CFU/gram, P<0.001) when compared with placebo.

    Safety:

    Adverse events for AZLI and placebo were comparable except the incidence of “productive cough” was reduced by half in AZLI-treated patients. Adverse events were consistent with symptoms of CF lung disease.

  • Citation:

    Chest 2009;135(5):1223-32

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:

    42 days

  • Number of Study Visits:

    5

Additional Information

Eligibility

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 75%

  • 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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