A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects with Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas aeruginosa Infection

Date Added
June 14th, 2023
PRO Number
Pro00128304
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of AP-PA02 administered by inhalation. This study will evaluate AP-PA02 administration in stable NCFB (non-cystic fibrosis bronchiectasis) patients. Subjects will either be included in Cohort A or Cohort B. For Cohort A, subjects will be randomized to receive either inhaled AP-PA02 or placebo. Cohort A will include individuals with NCFB and confirmed chronic P. aeruginosa infection but not on chronic inhaled antibiotics. These individuals will receive wither AP-PA02 or placebo for 10 days twice a day.
Cohort B will include individuals who with NCFB and confirmed P. aeruginosa infection but who are on chronic antibiotics. These individuals will receive either AP-PA02 or placebo for 10 days plus their current inhaled antibiotics for 28 days.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu