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RECRUITINGPhase 2INTERVENTIONAL

Study With Phage for CF Subjects With Pseudomonas Lung Infection

A Phase 2b, 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 Infection

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).

Who May Be Eligible (Plain English)

Key Who May Qualify: - Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics - Age ≥ 18 years - FEV1 40%-80% 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. Key Who Should NOT Join This Trial: - Known hypersensitivity to bacteriophages or excipients in the formulation. - Receipt of prior bacteriophage therapy within the 6 months prior to Screening or Day 1 - Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture - Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis - Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening - History of severe neutropenia - History of lung transplant - History of solid organ transplant - Acquired or primary weakened immune system syndrome - Initiation or change in type of CFTR modulator less than 3 months prior to Screening - Pregnant or breastfeeding female Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics * Age ≥ 18 years * FEV1 40%-80% 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. Key Exclusion Criteria: * Known hypersensitivity to bacteriophages or excipients in the formulation. * Receipt of prior bacteriophage therapy within the 6 months prior to Screening or Day 1 * Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture * Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis * Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening * History of severe neutropenia * History of lung transplant * History of solid organ transplant * Acquired or primary immunodeficiency syndrome * Initiation or change in type of CFTR modulator less than 3 months prior to Screening * Pregnant or breastfeeding female

Treatments Being Tested

BIOLOGICAL

BX004

Bacteriophage

OTHER

Placebo

Placebo

Locations (14)

University of Alabama at Birmingham
Birmingham, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Stanford University
Palo Alto, California, United States
University of California San Francisco
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Joe DiMaggio Children's Health
Hollywood, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Avanza Medical Center
Pensacola, Florida, United States
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
New York Medical College
Hawthorne, New York, United States
Northwell Health
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States