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Clinical Trial Finder
Anti-Infective Completed with Results
Study to evaluate BX004 in adults with cystic fibrosis and chronic Pseudomonas aeruginosa infections. (BiomX BMX-04-002)
This study tested the effectiveness of nebulized BX004, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. BX004 was tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (PsA).
This study was randomized and placebo controlled. This means that some participants received BX004 and some received a placebo. Researchers evaluated whether BX004 reduces the amount of Pseudomonas in sputum and improves lung function. Researchers measured safety and tolerability by monitoring for adverse events
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 80%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants must be taking either inhaled tobramycin or inhaled aztreonam or no inhaled antibiotics. Alternating Cayston/Tobi is excluded.
Study Results
-
What We Learned:
An independent data monitoring committee performed a safety review, after which the sponsor decided not to continue this study. The reason for ending the study early was because participants experienced adverse events more frequently than expected. The sponsor has shared this information through a press release:
https://ir.biomx.com/news-releases/news-release-details/biomx-announces-discontinuation-phase-2b-bx004-trial-following -
Primary Findings:
Effectiveness:
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
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
8 months -
Number of Study Visits:
9
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
BiomX -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40 to 80% -
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
Potential participants must be taking either inhaled tobramycin or inhaled aztreonam or no inhaled antibiotics. Alternating Cayston/Tobi is excluded.
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