Non-cystic Fibrosis BronchiectasisPhase 2TailwindNCT05616221

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

A Phase 2 study testing AP-PA02 in people with Non-cystic Fibrosis Bronchiectasis and Pseudomonas Aeruginosa, run by Armata Pharmaceuticals, Inc. at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
What is being tested?: AP-PA02
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 23 sitesUnited States
Study dates: 10 Jan 2023to 8 Aug 2024
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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

Who cannot join

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

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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 receiving treatment for active infection at any site
Female pregnant of breastfeeding

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
St. Lukes Hospital
Boise, Idaho, 83702
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati - College of Medicine
Cincinnati, Ohio, 45267
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106
UCONN Health
Farmington, Connecticut, 06030
Southwest General Healthcare Center
Fort Myers, Florida, 33907
New York Medical College
Hawthorne, New York, 10595
TecTum Medical Research, Inc.
Hollywood, Florida, 33024
Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
Jacksonville, Florida, 32224
The University of Kansas Medical Center / Dept of Medicine
Kansas City, Kansas, 66160
Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33146
Velocity Clinical Research
Mobile, Alabama, 36608
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
University of Pennslyvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington Medical Center
Seattle, Washington, 98195
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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

Read the detailed description

This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Cohort B will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Subjects in both Cohorts A and B will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.

Conditions: Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
Being tested: AP-PA02, Placebo
Keywords: Bacteriophage, Phage, NCFB, BE, Pseudomonas, Pseudomonas Aeruginosa
Medical subject headings: Pseudomonas Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AP-PA02Biological
Bacteriophage administered via inhalation
PlaceboOther
Inactive Placebo administered via inhalation

Study groups in NCT05616221
Study group	Role	What they receive
AP-PA02	Experimental	Anti-pseudomonal bacteriophage Receives: Biological: AP-PA02
Placebo	Placebo comparator	Inactive isotonic solution Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
Measured: Day 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 20238 Aug 2024

First posted15 Nov 2022
Study start10 Jan 2023
Primary completion17 Jul 2024
Study completion8 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blind, randomized, placebo-controlled
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05616221
Sponsor's protocol ID: AP-PA02-201
Acronym: Tailwind
Status last verified: Nov 2025
First submitted: 7 Nov 2022
Last updated: 5 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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