Chronic Pseudomonas aeruginosa Pulmonary Infection cystic fibrosis
Conditions
Interventions
Either twice daily High Dose inhaled BX004-A or placebo for 10 consecutive days
in addition to the usual regimen of inhaled antibiotics.
Sponsors
BiomX Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications. 2. Age >= 18 years 3. FEV1 >= 40% predicted 4. Clinically stable lung disease 5. Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to bacteriophages, simethicone, or excipients in the formulation 2. Receipt of prior bacteriophage therapy (BT) within the 6 months prior to Screening 3. Recovery of Burkholderia species from respiratory tract within 1 year prior to screening 4. Currently receiving treatment for allergic bronchopulmonary aspergillosis 5. Currently having treatment for active infection with non-tuberculous mycobacteria 6. History of severe neutropenia 7. History of lung transplant 8. History of solid organ transplant 9. Acquired or primary immunodeficiency syndrome 10. Initiation or change in type of CF modulator therapy less than 3 months prior to screening 11. Pregnant (or planning to become pregnant) or breastfeeding female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of nebulized BX004-A in CF subjects with chronic PsA pulmonary infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effect of BX004-A on sputum PsA burden, lung function, frequency of APEs, and quality of life at various timepoints. | — |
Countries
Netherlands
Outcome results
None listed