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 (Tailwind)

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety, and phage kinetics of multiple inhaled doses of AP-PA02 administered as monotherapy and administered in combination with inhaled antibiotics compared to placebo and inhaled antibiotics alone.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

- ≥ 18 years old.
- Body mass index (BMI) of ≥ 18 kg/m^2.
- 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.

Key Exclusion Criteria:

- 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.
- 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.

Eligibility last updated 12/30/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Harry Powers, M.D.

Closed for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Aksamit, M.D.

Closed for enrollment

Contact information:

Kayla Quinn

5075380595

quinn.kayla2@mayo.edu

More information

Publications

Publications are currently not available