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Anti-Infective Completed with Results

Aztreonam Lysinate for Inhalation in Individuals who Utilize Inhaled Tobramycin Frequently (AIR-CF2) (CP-AI-005)

People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, into a vein (IV), or inhaled as a mist. The purpose of this study was to see if aztreonam lysinate for inhalation (AI), an investigational formulation of the antibiotic for delivery using the eFlow® Electronic Nebulizer by PARI GmbH, is safe and effective in CF patients with PA.

 

Eligibility

See other primary eligibility criteria for more information.

  • 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.

Other Primary Eligibility Criteria

To be included in this study patients must have received three or more courses of TSI (tobramycin solution for inhalation) within the previous 12 months.

Study Results

  • What We Learned:

  • Primary Findings:

    Effectiveness:

    Following randomization and a 28-day course of tobramycin inhalation solution (TIS), 211 patients who were >6 years old, who had >3 courses of TOBI within the previous year, and who had an FEV1 betwen >25% and <75% of predicted were treated with 75 mg AZLI or placebo, twice or three times daily for 28 days, then monitored for 56 days. The primary efficacy endpoint was time to need for additional inhaled or IV antipseudomonal antibiotics. AZLI treatment increased median time to need for additional antipseudomonal antibiotics for symptoms of pulmonary exacerbation by 21 days, compared with placebo (AZLI, 92 days; placebo, 71 days; P=0.007).

     

    AZLI also improved mean CFQ-R Respiratory scores (5.01 points, P=0.02), improved FEV1 (6.3%, P=0.001), and decreased sputum PA density (-0.66 log10 CFU/gram, P=0.006) compared with placebo.

    Safety:

    Adverse events reported for AZLI and placebo were comparable and consistent with CF lung disease.

  • Citation:

    Am J Respir Crit Care Med 2008;178(9):921-8

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:

    18 weeks

  • Number of Study Visits:

    9

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • 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.

Other Primary Eligibility Criteria

To be included in this study patients must have received three or more courses of TSI (tobramycin solution for inhalation) within the previous 12 months.

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