Search

Page Title

Clinical Trial Finder

Back to the Clinical Trial Finder

Anti-Infective Completed with Results

AZLI (Inhaled Aztreonam) for People with Cystic Fibrosis and Chronic Burkholderia Infection (Gilead GS-US-205-0127)

This phase 3 study looked at the safety and effectiveness of inhaled aztreonam (Cayston®) in people with Cystic Fibrosis and chronic Burkholderia cepacia infection. Burholderia cepacia remains a difficult organism to treat and this study was conducted to determine the safety and effectiveness of long-term continuous treatment with inhaled aztreonam in people with CF and Burkholderia lung infections. Participants were randomized to inhaled aztreonam or placebo given three times a day for 24 weeks. This was followed by an additional 24 weeks open-label period where all participants received inhaled aztreonam.

 

Eligibility

  • Age:

    6 Years and Older

  • 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 was no significant change in lung function in the treatment group compared to the placebo group. Additionally, inhaled aztreonam was well-tolerated.

  • Primary Findings:

    Effectiveness:

    This study was conducted between February 2010 and September 2011. A total of 101 people with CF participated in this study and 84 participants continued into the open label phase. No significant difference was observed for the primary endpoint, change from baseline FEV1% predicted between inhaled aztreonam and placebo.

     

    Similarly, no significant differences were seen in the number of respiratory exacerbations requiring treatment with either systemic or inhaled antibiotics or the number of hospitalizations.

    Safety:

    Continuous inhaled aztreonam treatment through 48 weeks was well tolerated. Burkholderia susceptibility to many of the antibiotics commonly used in CF showed little change.

  • Citation:

    J Cyst Fibros 2014;13(3):296-305

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:

    48 weeks

  • Number of Study Visits:

    15

Additional Information

Eligibility

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

  • B. Cepacia Status:

    Positive Respiratory Cultures Required

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

Sign up for clinical trial alerts

Get email updates about clinical trials that matter to you.

Check the Drug Development Pipeline

We’re attacking CF from every angle. Learn about the status of CF drugs in development.

Learn More