Clinical study
Tailwind
| Status | Completed |
|---|---|
| Type | Trial |
| Countries | United States |
| Conditions studied | Non-cystic Fibrosis Bronchiectasis; Pseudomonas Aeruginosa; Lung Infection |
| Study years | 2023–2024 |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
Key Inclusion Criteria: * ≥ 18 years old * 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 Key Exclusion Criteria: * Abnormal vital signs at Screening * 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
Study description
Official study title
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
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.
Study registrations
| ClinicalTrials.gov | NCT05616221 |
|---|
Recorded study locations (23)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Velocity Clinical Research
Mobile, Alabama, United States
Recorded site status: Not separately listed. Study location source ↗
Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
Los Angeles, California, United States
Recorded site status: Not separately listed. Study location source ↗
UCONN Health
Farmington, Connecticut, United States
Recorded site status: Not separately listed. Study location source ↗
Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
Washington D.C., District of Columbia, United States
Recorded site status: Not separately listed. Study location source ↗
Southwest General Healthcare Center
Fort Myers, Florida, United States
Recorded site status: Not separately listed. Study location source ↗
TecTum Medical Research, Inc.
Hollywood, Florida, United States
Recorded site status: Not separately listed. Study location source ↗
Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
Jacksonville, Florida, United States
Recorded site status: Not separately listed. Study location source ↗
University of Miami
Miami, Florida, United States
Recorded site status: Not separately listed. Study location source ↗
St. Lukes Hospital
Boise, Idaho, United States
Recorded site status: Not separately listed. Study location source ↗
The University of Kansas Medical Center / Dept of Medicine
Kansas City, Kansas, United States
Recorded site status: Not separately listed. Study location source ↗
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Recorded site status: Not separately listed. Study location source ↗
Mayo Clinic
Rochester, Minnesota, United States
Recorded site status: Not separately listed. Study location source ↗
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Recorded site status: Not separately listed. Study location source ↗
New York Medical College
Hawthorne, New York, United States
Recorded site status: Not separately listed. Study location source ↗
University of Cincinnati - College of Medicine
Cincinnati, Ohio, United States
Recorded site status: Not separately listed. Study location source ↗
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, United States
Recorded site status: Not separately listed. Study location source ↗
Oregon Health & Science University
Portland, Oregon, United States
Recorded site status: Not separately listed. Study location source ↗
University of Pennslyvania
Philadelphia, Pennsylvania, United States
Recorded site status: Not separately listed. Study location source ↗
Medical University of South Carolina
Charleston, South Carolina, United States
Recorded site status: Not separately listed. Study location source ↗
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recorded site status: Not separately listed. Study location source ↗
University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Recorded site status: Not separately listed. Study location source ↗
Virginia Commonwealth University (VCU)
Richmond, Virginia, United States
Recorded site status: Not separately listed. Study location source ↗
University of Washington Medical Center
Seattle, Washington, United States
Recorded site status: Not separately listed. Study location source ↗
Related programs(1)
Armata Pharmaceuticals
Research/development
Recorded program–study link. Website
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct05616221 |
|---|