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 (Tailwind)
Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
About this trial
This is an interventional treatment trial for Non-cystic Fibrosis Bronchiectasis focused on measuring Bacteriophage, Phage, NCFB, BE, Pseudomonas, Pseudomonas Aeruginosa
Eligibility Criteria
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
Sites / Locations
- Velocity Clinical ResearchRecruiting
- Southern California Institute for Respiratory Diseases Cedars-Sinai West TowerRecruiting
- UCONN HealthRecruiting
- Georgetown University Hospital / Pulmonary Critical Care and Sleep MedicineRecruiting
- Southwest General Healthcare CenterRecruiting
- TecTum Medical Research, Inc.Recruiting
- Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
- University of MiamiRecruiting
- St. Lukes HospitalRecruiting
- The University of Kansas Medical Center / Dept of MedicineRecruiting
- Mayo Clinic
- Rutgers Robert Wood Johnson Medical SchoolRecruiting
- Oregon Health & Science UniversityRecruiting
- Medical University of South CarolinaRecruiting
- University of Texas Health Science Center at TylerRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
AP-PA02
Placebo
Anti-pseudomonal bacteriophage
Inactive isotonic solution