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Virus Therapy
Inhaled Phage Therapy for Bronchiectasis (Tailwind Trial)
Phase 2
Waitlist Available
Research Sponsored by Armata Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial tests an inhaled treatment called AP-PA02 for patients with a persistent lung infection caused by Pseudomonas aeruginosa. The treatment uses tiny viruses to kill the harmful bacteria in the lungs. The study aims to see if this new approach is safe and effective.
Who is the study for?
Adults over 18 with non-cystic fibrosis bronchiectasis and chronic lung infection caused by Pseudomonas aeruginosa. Participants must have a BMI of ≥ 18 kg/m2, evidence of bronchiectasis on CT scan, and be able to produce sputum samples. Exclusions include abnormal vital signs, immune deficiencies, significant weight loss, certain heart conditions, history of lung transplant or cystic fibrosis, recent changes in respiratory treatments or active infections elsewhere.
What is being tested?
The trial is testing AP-PA02—an inhaled treatment—against a placebo for safety and effectiveness in treating chronic pulmonary Pseudomonas aeruginosa infection. This phase 2 study randomly assigns participants to receive either the real drug or a placebo without them knowing which one they're getting.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include irritation at the site of inhalation, coughing fits during administration, potential allergic reactions to components within AP-PA02 therapy or general discomfort associated with inhaling medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 1 & 2 trial • 29 Patients • NCT0459631933%
vaccination complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 SAD
MAD Placebo
Cohort 3 MAD
SAD Placebo
Cohort 2 SAD
Cohort 4 MAD
Amendment 5 MAD
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AP-PA02Experimental Treatment1 Intervention
Anti-pseudomonal bacteriophage
Group II: PlaceboPlacebo Group1 Intervention
Inactive isotonic solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AP-PA02
2020
Completed Phase 2
~80
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pneumonia include antibiotics, which target and kill the bacteria causing the infection, and supportive care such as oxygen therapy and fluids. Antibiotics like macrolides, beta-lactams, and fluoroquinolones disrupt bacterial cell wall synthesis, protein synthesis, or DNA replication, leading to bacterial death.
Inhaled AP-PA02, a bacteriophage therapy, specifically targets Pseudomonas aeruginosa by infecting and lysing the bacterial cells. This is particularly important for pneumonia patients with chronic Pseudomonas infections, as it offers a targeted approach that can reduce bacterial load and improve outcomes, especially in cases where antibiotic resistance is a concern.
Morpholino oligomers tested in vitro, in biofilm and in vivo against multidrug-resistant Klebsiella pneumoniae.
Morpholino oligomers tested in vitro, in biofilm and in vivo against multidrug-resistant Klebsiella pneumoniae.
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Who is running the clinical trial?
Armata Pharmaceuticals, Inc.Lead Sponsor
12 Previous Clinical Trials
485 Total Patients Enrolled
Mina Pastagia, MDStudy DirectorArmata Pharmaceuticals, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a condition that weakens your immune system.You have lost a lot of weight recently.You have a history of prolonged QT syndrome.You have had a lung transplant in the past.You have had cystic fibrosis in the past.You have a history of α1-antitrypsin deficiency.You have a history of coughing up blood.You have recently started or changed your medications for conditions such as respiratory or lung problems.You are 18 years old or older.You need to have a body mass index (BMI) of 18 or higher.Evidence of bronchiectasis seen on a CT scan.You have a long-term infection in your lungs caused by Pseudomonas aeruginosa.You have been using certain antibiotics through inhalation for at least 3 months before starting the study.You have used cigarettes, cigars, pipes, or vaping products recently.You have recently needed to use extra oxygen during the day when you are not active.Your lung function is at least 35% of what is expected for someone your age and size.You have a history of chronic obstructive pulmonary disease (COPD).You have had lung cancer or any other type of cancer that needed treatment.
Research Study Groups:
This trial has the following groups:- Group 1: AP-PA02
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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