Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

Prior treatment

• Receipt of prior bacteriophage therapy within the 6 months prior to Screening
• Recovery of Burkholderia species from respiratory tract within 1 year prior to screening
• Currently receiving treatment for allergic bronchopulmonary aspergillosis
• Currently receiving treatment for active infection with non-tuberculous mycobacteria
• Initiation or change in CF modulator therapy less than 3 months prior to screening

Other illness

• Known hypersensitivity to bacteriophages or excipients in the formulation.
• History of severe neutropenia
• History of lung transplant
• History of solid organ transplant
• Acquired or primary immunodeficiency syndrome

Other

• Pregnant or breastfeeding female

• Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
• Age ≥ 18 years
• FEV1 ≥ 40% predicted
• Clinically stable lung disease
• Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.