An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL) (SAIL)

November 3, 2026 updated by: Avalyn Pharma Inc.

A Multinational, Long-Term, Safety and Tolerability, Open-Label Extension Study of Subjects Who Have Participated in Avalyn Pharma Studies of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System.

The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug.

A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1056ABI
        • Recruiting
        • CINME
        • Principal Investigator:
          • Maria Otaola
        • Contact:
          • Maria Otaola
        • Contact:
      • Buenos Aires, Argentina, 7600
        • Recruiting
        • Instituto Ave Pulmo, Fundacion Enfisema
        • Principal Investigator:
          • Luis Wehbe
        • Contact:
      • Buenos Aires, Argentina, C1199ABH
      • Buenos Aires, Argentina, 1842
        • Recruiting
        • Clinica Monte Grande
        • Contact:
      • Buenos Aires, Argentina, B1878
      • Buenos Aires, Argentina, 1427
        • Recruiting
        • Fundación Respirar
        • Principal Investigator:
          • Pablo Doreski
        • Contact:
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000CBC
        • Recruiting
        • CIMER Centro Integral de Medicina Respiratoria
        • Principal Investigator:
          • Hector Altieri
        • Contact:
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAP
        • Recruiting
        • Investigaciones En Patologias Respiratorias
        • Principal Investigator:
          • Ramon Angel Rosas
        • Contact:
  • Australia
      • Chermside, Australia
      • Footscray, Australia
        • Recruiting
        • Lung & Sleep Victoria
        • Principal Investigator:
          • Ian Glaspole
        • Contact:
      • Kent Town, Australia
        • Recruiting
        • Respiratory Clinical Trials PTY Ltd
        • Principal Investigator:
          • Michael Chia
        • Contact:
      • Kingston, Australia
      • Nedlands, Australia
        • Recruiting
        • Univ of Western Australia / Institute for Respiratory Health
        • Principal Investigator:
          • Vidya Navaratnam
        • Contact:
      • New Lambton Heights, Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Macquarie Park, New South Wales, Australia, 2113
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Recruiting
        • Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
        • Principal Investigator:
          • Daniel Chambers
        • Contact:
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Active, not recruiting
        • The Queen Elizabeth Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • Alfred Health
        • Contact:
        • Principal Investigator:
          • Jun Keng Khoo
  • Canada
    • Ontario
      • Ajax, Ontario, Canada
        • Recruiting
        • Dynamic Drug Advancement
        • Principal Investigator:
          • George Philteos
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Research Institute McGill University Health Center
        • Principal Investigator:
          • Deborah Assayag
        • Contact:
      • Trois-Rivières, Quebec, Canada, G8T 7A1
    • Vancouver
      • Vancouver, Vancouver, Canada, V5Z1M9
        • Recruiting
        • Centre for Lung Health
        • Principal Investigator:
          • Daniel Marinescu
        • Contact:
  • Czechia
      • Praha Klanovice, Czechia
        • Recruiting
        • Fakultni Thomayerove nemocnice
        • Principal Investigator:
          • Martina Sterclova
        • Contact:
  • France
      • Angers, France, 49933
        • Recruiting
        • Centre Hospitalier Universitaire d'Angers
        • Contact:
        • Principal Investigator:
          • Frederick Gagnadoux
    • Montpellier
      • Montrevel-en-Bresse, Montpellier, France, 34090
  • Germany
      • Frankfurt, Germany, 60389
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Jonas Schupp
        • Contact:
    • State of Berlin
      • Berlin, State of Berlin, Germany, 12351
        • Recruiting
        • Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie
        • Contact:
        • Principal Investigator:
          • Sven Gläser
  • Italy
      • Milan, Italy, 20123
        • Recruiting
        • Ospedale San Giuseppe/ MultiMedica SPA
        • Principal Investigator:
          • Sergio Harari
        • Contact:
      • Milan, Italy, 20089
        • Recruiting
        • HUMANITAS Research Hospital
        • Principal Investigator:
          • Francesco Amati
        • Contact:
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
        • Principal Investigator:
          • Angelo Guido Corsico
        • Contact:
  • Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands, 3015
        • Recruiting
        • Erasmus University Medical Center
        • Contact:
          • Thomas Koudstaal
        • Principal Investigator:
          • Thomas Koudstaal
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Active, not recruiting
        • Dunedin Hospital
      • Hamilton, New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand
        • Recruiting
        • Greenlane Clinical Centre
        • Principal Investigator:
          • Margaret Wilsher
        • Contact:
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
    • Tauranga
      • Tauranga, Tauranga, New Zealand, 3112
        • Recruiting
        • Bay of Plenty Clinical Trials Unit
        • Principal Investigator:
          • Suzanne Poole
        • Contact:
  • Poland
      • Gdansk, Poland, 80211
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Contact:
        • Principal Investigator:
          • Amelia Szymanowska-Narloch
      • Lodz, Poland, 90315
        • Recruiting
        • Department of Pneumology of the University Hospital No 1
        • Principal Investigator:
          • Wojciech Piotrowski
        • Contact:
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-602
        • Recruiting
        • Prywatny Gabinet Lekarski Ginekologia I Połoznictwo Ultrasonografia
        • Contact:
        • Principal Investigator:
          • Izabela Grabska- Kobylecka
  • Spain
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Principal Investigator:
          • Jose Luis Velasco Garrido
        • Contact:
    • Andalusia
      • Granada, Andalusia, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Principal Investigator:
          • Ana Dolores Romero Ortiz
        • Contact:
    • Barcelona
      • Barcelona, Barcelona, Spain, 08908
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
        • Principal Investigator:
          • José Cifrian
    • Madrid
      • Madrid, Madrid, Spain, 28034
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • Juan Rigual
      • Madrid, Madrid, Spain
        • Recruiting
        • Hospital Gregorio Marañon
        • Principal Investigator:
          • Luis Puente Maestu
        • Contact:
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0AY
        • Recruiting
        • Royal Papworth Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Helen Parfrey
      • Leicester, United Kingdom
        • Recruiting
        • Leicester Biomedical Research Centre
        • Principal Investigator:
          • Charlotte Swales
        • Contact:
      • London, United Kingdom, SW17 0RE
        • Recruiting
        • St. George's University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Aul Raminder
        • Contact:
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon
        • Contact:
          • Michael Gibbons
        • Principal Investigator:
          • Michael Gibbons
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • Recruiting
        • Hull University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Simon Hart
    • London
      • London, London, United Kingdom, SW3 6NP
        • Not yet recruiting
        • Royal Brompton Hospital
        • Contact:
          • Peter George
        • Principal Investigator:
          • Peter George
    • South East England
      • Oxford, South East England, United Kingdom, OX3 7LE
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Rachel Hoyles
        • Contact:
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Not yet recruiting
        • University Hospitals of North Midlands NHS Trust
        • Principal Investigator:
          • Helen Stone
        • Contact:
          • Helen Stone
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • Recruiting
        • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
        • Principal Investigator:
          • Anjali Crawshaw
        • Contact:
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • St James University Hospital
        • Contact:
          • Paul Beirne
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Tejaswini Kulkarni
        • Contact:
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Toby Maher
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Newport Native MD, Inc.
        • Principal Investigator:
          • Ryan Klein
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado, Anschutz Medical Campus
        • Principal Investigator:
          • Joyce Lee, MD
        • Contact:
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • UConn Health
        • Contact:
          • Ameer Rasheed
        • Principal Investigator:
          • Ameer Rasheed
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Mridu Gulati
    • Florida
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Renstar Medical Research
        • Principal Investigator:
          • Raj Karunakara, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare, Inc.
        • Principal Investigator:
          • Amy Case, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Medical Center
        • Principal Investigator:
          • Mark Hamblin
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins Asthma and Allergy Center
        • Principal Investigator:
          • Matthew Lammi, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
          • Sam Nascak
        • Principal Investigator:
          • Andrew Limper, MD
        • Contact:
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Recruiting
        • Hannibal Regional Healthcare System, Inc.
        • Principal Investigator:
          • Humam Farah, MD
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Maria Padilla, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Claire McGroder, MD
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell
        • Principal Investigator:
          • Anna Podolanczuk
        • Contact:
    • North Carolina
      • Statesville, North Carolina, United States, 28625
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Nishant Gupta, MD
        • Contact:
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Summit Health
        • Principal Investigator:
          • Jeremy Feldman, MD
        • Contact:
      • Portland, Oregon, United States, 97220
        • Recruiting
        • The Oregon Clinic Pulmonary East
        • Principal Investigator:
          • David Hotchkin
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Ross Summer, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Timothy Whelan, MD
        • Contact:
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Lung and Critical Care, PA
        • Principal Investigator:
          • Thomas Kaelin, Jr., DO
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Justin Hewlett, MD
        • Contact:
    • Texas
      • El Paso, Texas, United States, 79902
        • Recruiting
        • El Paso Pulmonary Association, P.A.
        • Principal Investigator:
          • Carlo Hatem, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Ivan Rosas
        • Contact:
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Peter Crossno, MD
        • Contact:
      • Salt Lake City, Utah, United States, 84108
    • Virginia
      • Falls Church, Virginia, United States, 22042
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Suha Kadura
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.

Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).

  • Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.

Exclusion Criteria:

  • Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
  • Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).
  • Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
  • Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.
  • History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Open-label AP01 treatment arm

All trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability.
Combination product: AP01

AP01 will be administered open-label via the eFlow Nebulizer System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).
Time Frame: Through end of study; average of 6 years

The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), oxygen saturation, spirometry, physical exams, blood chemistry, and quality of life assessments.
Through end of study; average of 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on lung function the change from baseline in forced vital capacity (FVC) will be evaluated.
Time Frame: Through end of study; average of 6 years

FVC will be evaluated via spirometry.
Through end of study; average of 6 years
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on stabilization of disease.
Time Frame: Through end of study; average of 6 years

Stabilization of disease will be based on computational analysis of quantitative high-resolution computed tomography (HRCT) to assess the extent and pattern of interstitial lung disease present on the HRCT scans (methodologies developed by Qureight).
Through end of study; average of 6 years
To evaluate the long-term impact of Avalyn nebulized antifibrotic medications on subject-reported quality of life (QoL).
Time Frame: Through end of study; average of 6 years

This outcome will evaluate the change from baseline in the 'Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire' (L-PF) total score. The L-PF is a 23-point questionnaire with lower scores equating to 'less symptomatic' and higher scores equating to 'more symptomatic.'
Through end of study; average of 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avalyn Pharma Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Avalyn Pharma, Inc., Avalyn Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AP-LTE-008
  • ACTRN12625000246482 (Registry Identifier: Australian New Zealand Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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