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.
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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 15Show fewer
- 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.
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
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
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 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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05616221
- Acronym / sponsor ID
- Tailwind / AP-PA02-201
- Keywords
- Bacteriophage, Phage, NCFB, BE, Pseudomonas, Pseudomonas Aeruginosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Posted 5 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| AP-PA02 | Experimental | Biological: AP-PA02Anti-pseudomonal bacteriophage |
| Placebo | Placebo comparator | Other: PlaceboInactive isotonic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP-PA02Bacteriophage administered via inhalation | Biological | AP-PA02 |
| PlaceboInactive Placebo administered via inhalation | Other | Placebo |
Primary outcome
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
Time frame: Day 17
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Armata Pharmaceuticals, Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non-cystic Fibrosis Bronchiectasis
Recruiting
Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
RecruitingPhase 2
A Phase II Study of Ensifentrine in Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation (time frame: Day 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.