Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With No… (NCT05616221) | Clinical Trial Compass
CompletedPhase 2
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
United States48 participantsStarted 2023-01-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 receivin…
What they're measuring
1
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation