Cystic fibrosis Chronic Pseudomonas Aeruginosa Infection MedDRA version: 20.0 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 22.1 Level: LLT Classification code 10082869 Term: Chronic Pseudomonas aeruginosa infection System Organ Class: 100000004862
Conditions
Interventions
Product Code: DPPSA771-1/1 (part of BX004-A combination)
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: not applicable
Other descriptive name: IHMA-2121771-1
Concentration unit: PFU/ml
Sponsors
BiomX Ltd.
Eligibility
Sex/Gender
All
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to bacteriophages or excipients in the formulation. 2. Receipt of prior bacteriophage therapy 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 receiving 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 CF modulator therapy less than 3 months prior to screening 11. Pregnant or breastfeeding female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of nebulized BX004-A in CF subjects with chronic PsA pulmonary infection.;Secondary Objective: not applicable;Primary end point(s): Safety and tolerability, as assessed by vital sign measurements, pulmonary examination, laboratory tests, spirometry and adverse events;Timepoint(s) of evaluation of this end point: Safety will be assessed at every clinic visit: D1, D2, D3, D4, D8, D15 (also D35 phone call and 6 month phone call) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Czechia, Czech Republic, Israel, Netherlands, Spain, United States
Contacts
Public ContactClinical Trial Information
BiomX Ltd
Outcome results
None listed