A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infectio
- Conditions
- Chronic Pseudomonas aeruginosa Pulmonary Infectioncystic fibrosis100386861004743810024970
- Registration Number
- NL-OMON53309
- Lead Sponsor
- BiomX Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The safety and tolerability of nebulized BX004-A in CF subjects with chronic<br /><br>PsA pulmonary infection.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The effect of BX004-A on sputum PsA burden, lung function, frequency of APEs,<br /><br>and quality of life at various timepoints.</p><br>