Programs and studies

Clinical study

Tailwind

StatusCompleted
TypeTrial
CountriesUnited States
Conditions studiedNon-cystic Fibrosis Bronchiectasis; Pseudomonas Aeruginosa; Lung Infection
Study years2023–2024
Entry review2026-10-03

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.govNCT05616221
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)

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