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Virus Therapy
Inhaled Phage Therapy for Bronchiectasis (Tailwind Trial)
Phase 2
Recruiting
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 day 1 pre-dose through 7 days post last dose of study drug
Awards & highlights
Tailwind Trial Summary
This trial tests a new inhaled treatment for lung infection in those with bronchiectasis. Results will show safety, effectiveness and how the body reacts to it.
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.Check my eligibility
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.See study design
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.
Tailwind Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 pre-dose through 7 days post last dose of study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre-dose through 7 days post last dose of study drug
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation
Side effects data
From 2022 Phase 1 & 2 trial • 29 Patients • NCT0459631950%
Backache
50%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amendment 5 MAD
Cohort 1 SAD
Cohort 2 SAD
SAD Placebo
Cohort 3 MAD
MAD Placebo
Cohort 4 MAD
Tailwind 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
~30
Find a Location
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of participants in this clinical experiment?
"Affirmative. The records hosted on clinicaltrials.gov support that, since January 1st 2023, this experiment has been recruiting patients for the purpose of data collection. Specifically, 60 participants are needed from 2 separate medical facilities."
Answered by AI
What potential risks are associated with utilization of AP-PA02?
"The safety of AP-PA02 was given a rating of 2, as one can only presume its efficacy based on the limited data gathered in Phase 2 trials."
Answered by AI
Can new participants join this investigation currently?
"Affirmative. The information on clinicaltrials.gov specifies that the study is currently recruiting participants; this trial was first posted in January 1st 2023 and was recently updated on December 22nd 2022. This research needs to find 60 volunteers from two different sites."
Answered by AI
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