Phase
Condition
Bronchiectasis
Pressure Ulcers
Bronchitis (Pediatric)
Treatment
AP-PA02
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, andwilling to provide expectorated sputum samples at all other timepoints (for subjectswho 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 regimenfor at least 3 months prior to Visit 1
For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen forat least 3 months prior to Visit 1
Exclusion
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 sourceby vaping
Recent changes in either the treatment regimen or initiation of treatment with: oralmacrolides, hypertonic saline, mucolytics, bronchodilator medications, or oralcorticosteroids
Currently receiving treatment for active infection at any site
Female pregnant of breastfeeding
Study Design
Study Description
Connect with a study center
Velocity Clinical Research
Mobile, Alabama 36608
United StatesSite Not Available
Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
Los Angeles, California 90048
United StatesSite Not Available
UCONN Health
Farmington, Connecticut 06030
United StatesSite Not Available
Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
Washington, District of Columbia 20007
United StatesSite Not Available
Southwest General Healthcare Center
Fort Myers, Florida 33907
United StatesSite Not Available
TecTum Medical Research, Inc.
Hollywood, Florida 33024
United StatesSite Not Available
Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
Jacksonville, Florida 32224
United StatesSite Not Available
University of Miami
Miami, Florida 33146
United StatesSite Not Available
St. Lukes Hospital
Boise, Idaho 83702
United StatesSite Not Available
The University of Kansas Medical Center / Dept of Medicine
Kansas City, Kansas 66160
United StatesSite Not Available
Johns Hopkins University School of Medicine
Baltimore, Maryland 21224
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United StatesSite Not Available
New York Medical College
Hawthorne, New York 10595
United StatesSite Not Available
University of Cincinnati - College of Medicine
Cincinnati, Ohio 45267
United StatesSite Not Available
University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
University of Pennslyvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37203
United StatesSite Not Available
University of Texas Health Science Center at Tyler
Tyler, Texas 75708
United StatesSite Not Available
Virginia Commonwealth University (VCU)
Richmond, Virginia 23298
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available

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