Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
NCT ID: NCT05616221
Last Updated: 2026-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2023-01-10
2024-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AP-PA02
Anti-pseudomonal bacteriophage
AP-PA02
Bacteriophage administered via inhalation
Placebo
Inactive isotonic solution
Placebo
Inactive Placebo administered via inhalation
Interventions
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AP-PA02
Bacteriophage administered via inhalation
Placebo
Inactive Placebo administered via inhalation
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of ≥ 18 kg/m2
* Evidence of bronchiectasis per CT
* Evidence of chronic pulmonary Pseudomonas aeruginosa infection
* Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
* FEV1 ≥ 35% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening
* For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
* For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
Exclusion Criteria
* History of lung transplantation
* History of cystic fibrosis
* History of α1-antitrypsin deficiency
* History of primary or acquired immunodeficiency syndromes
* History of COPD
* History of pulmonary malignancy or any other malignancy requiring treatment
* History of prolonged QT syndrome
* History of hemoptysis
* Recent significant weight loss
* Recent use of supplemental oxygen during the day while at rest
* Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping
* Recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids
* Currently receiving treatment for active infection at any site
* Female pregnant of breastfeeding
18 Years
ALL
No
Sponsors
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Armata Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Velocity Clinical Research
Mobile, Alabama, United States
Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
Los Angeles, California, United States
UCONN Health
Farmington, Connecticut, United States
Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
Washington D.C., District of Columbia, United States
Southwest General Healthcare Center
Fort Myers, Florida, United States
TecTum Medical Research, Inc.
Hollywood, Florida, United States
Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
St. Lukes Hospital
Boise, Idaho, United States
The University of Kansas Medical Center / Dept of Medicine
Kansas City, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
New York Medical College
Hawthorne, New York, United States
University of Cincinnati - College of Medicine
Cincinnati, Ohio, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Armata Pharmaceuticals, Inc.
Other Identifiers
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AP-PA02-201
Identifier Type: -
Identifier Source: org_study_id
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