At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
AP-PA02 +1 morebiological
Likely dose
AP-PA02 administered via inhalation (specific dose not stated in criteria or arms)AI-extracted
Key inclusion· 8
- ✓Age ≥18 years old
- ✓BMI ≥18 kg/m²
- ✓Confirmed bronchiectasis on CT imaging
- ✓Chronic pulmonary Pseudomonas aeruginosa infection documented
Key exclusion· 15
- ✕Abnormal vital signs at screening
- ✕History of lung transplantation
- ✕History of cystic fibrosis
- ✕History of α1-antitrypsin deficiency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AP-PA02 and Placebo for Non-cystic Fibrosis Bronchiectasis and 2 related conditions. Completed, enrolled 48 participants across 23 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartJan 2023
Primary CompletionJul 2024
Study CompletionAug 2024
TodayJul 2026
First PostedNov 15, 2022
Enrollment StartJan 10, 2023
Primary CompletionJul 17, 2024
Study CompletionAug 8, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.6 years ago
Interventions
AP-PA02biological
Bacteriophage administered via inhalation
Placeboother
Inactive Placebo administered via inhalation