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

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: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF); Progressive Pulmonary Fibrosis
• Intervention / Treatment: Combination product: AP01

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: Interventional
• Enrollment (Estimated): 340
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dr. Felix Woodhead, MB BChir,PhD; Phone Number: +44 7999 885973; Email: fwoodhead@avalynpharma.com

Study Locations

• Australia
  • Camperdown, Australia
    • Recruiting
    • Royal Prince Alfred Hospital
    • Principal Investigator: Tamera Corte
    • Contact: Tamera Corte; Phone Number: (02) 95156120; Email: tamera.corte@health.nsw.gov.au
  • Chermside, Australia
    • Recruiting
    • The Prince Charles Hospital (TPCH)
    • Principal Investigator: Peter Hopkins
    • Contact: Peter Hopkins; Phone Number: 000-000-000; Email: peter_hopkins@health.qld.gov.au
  • Footscray, Australia
    • Recruiting
    • Lung & Sleep Victoria
    • Principal Investigator: Ian Glaspole
    • Contact: Ian Glaspole
  • Kent Town, Australia
    • Recruiting
    • Respiratory Clinical Trials PTY Ltd
    • Principal Investigator: Michael Chia
    • Contact: Michael Chia; Phone Number: 000-000-000; Email: mmchia@hotmail.com
  • Kingston, Australia
    • Recruiting
    • Nepean Lung & Sleep
    • Contact: Donald Lee
    • Principal Investigator: Donald Lee
  • Nedlands, Australia
    • Recruiting
    • Univ of Western Australia / Institute for Respiratory Health
    • Principal Investigator: Vidya Navaratnam
    • Contact: Vidya Navaratnam; Phone Number: 000-000-000; Email: Vidya.Navaratnam@health.wa.gov.au
  • New Lambton Heights, Australia
    • Recruiting
    • John Hunter Hospital
    • Contact: Christopher Grainge; Phone Number: 000-000-000; Email: christopher.grainge@health.nsw.gov.au
    • Principal Investigator: Christopher Grainge
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Principal Investigator: John Wheatley
      • Contact: John Wheatley; Phone Number: 000-000-000; Email: john.wheatley@sydney.edu.au
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • Active, not recruiting
      • The Queen Elizabeth Hospital
• Canada
  • Vancouver, Canada, V5Z1M9
    • Recruiting
    • Centre for Lung Health
    • Contact: Daniel Marinescu; Phone Number: 000-000-000
    • Principal Investigator: Daniel Marinescu
  • Ontario
    • Ajax, Ontario, Canada
      • Recruiting
      • Dynamic Drug Advancement
      • Principal Investigator: George Philteos
      • Contact: George Philteos; Phone Number: 000-000-000
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Research Institute McGill University Health Center
      • Principal Investigator: Deborah Assayag
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Recruiting
      • CIC Mauricie
      • Contact: Emilie Millaire; Phone Number: 000-000-000
      • Principal Investigator: Emilie Millaire
• Czechia
  • Praha Klanovice, Czechia
    • Recruiting
    • Fakultni Thomayerove nemocnice
    • Contact: Martina Sterclova; Phone Number: 000-000-000; Email: martina.sterclova@ftn.cz
    • Principal Investigator: Martina Sterclova
• France
  • Angers, France, 49933
    • Recruiting
    • Centre Hospitalier Universitaire d'Angers
    • Contact: Frederic Gagnadoux, MD
  • Montpellier
    • Montrevel-en-Bresse, Montpellier, France, 34090
      • Recruiting
      • University of Montpellier
      • Contact: Arnaud Bourdin
      • Principal Investigator: Arnaud BOURDIN
      • Contact: Arnaud Bourdin; Phone Number: 000-000-000
• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Recruiting
      • Medizinische Hochschule Hannover
      • Principal Investigator: Jonas Schupp
• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
      • Contact: Angelo Guido Corsico, MD
• Netherlands
  • Nieuwegein, Netherlands
    • Recruiting
    • St Antonius Hospital
    • Principal Investigator: Marcel Veltkamp
    • Contact: Marcel Veltkamp; Phone Number: 0031 88 320 14 25; Email: m.veltkamp@antoniusziekenhuis.nl
• New Zealand
  • Auckland, New Zealand
    • Recruiting
    • Greenlane Clinical Centre
    • Contact: Margaret Wilsher; Phone Number: 000-000-000; Email: mwilsher@adhb.govt.nz
    • Principal Investigator: Margaret Wilsher
  • Dunedin, New Zealand, 9016
    • Active, not recruiting
    • Dunedin Hospital
  • Hamilton, New Zealand
    • Recruiting
    • Waikato Hospital
    • Principal Investigator: Catherina Chang
    • Contact: Catherina Chang; Phone Number: 000-000-000; Email: cat.chang@waikatodhb.health.nz
  • Tauranga, New Zealand, 3112
    • Recruiting
    • Bay of Plenty Clinical Trials Unit
    • Principal Investigator: Suzanne Poole
• Poland
  • Gdansk, Poland, 80211
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
    • Contact: Amelia Szymanowska-Narloch, MD
  • Lodz, Poland, 90315
    • Recruiting
    • Department of Pneumology of the University Hospital No 1
    • Contact: Wojciech Piotrowski, MD, PhD
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Gregorio Marañón
    • Contact: Luis Puente Maestu; Phone Number: 000-000-000
    • Principal Investigator: Luis Puente Maestu
• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Recruiting
    • Royal Papworth Hospital NHS Foundation Trust
    • Contact: Helen Parfrey, MD
  • Leicester, United Kingdom
    • Recruiting
    • Leicester Biomedical Research Centre
    • Contact: Charlotte Swales; Phone Number: 0044116 2583825; Email: Charlotte.Swales@uhl-tr.nhs.uk
    • Principal Investigator: Charlotte Swales
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Recruiting
      • Hull University Teaching Hospital
      • Principal Investigator: Simon Hart
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • University of Alabama at Birmingham
      • Principal Investigator: Tejaswini Kulkarni
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Principal Investigator: Toby Maher
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado, Anschutz Medical Campus
      • Contact: Joyce Lee
      • Principal Investigator: Joyce Lee, MD
  • Florida
    • Ocala, Florida, United States, 34470
      • Recruiting
      • Renstar Medical Research
      • Contact: Raj Karunakara
      • Principal Investigator: Raj Karunakara, MD
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Healthcare, Inc.
      • Principal Investigator: Amy Case, MD
      • Contact: Amy Case
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Principal Investigator: Edward Britt
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Recruiting
      • Mayo Clinic Rochester
      • Contact: Sam Nascak
      • Contact: Andrew Limper
      • Principal Investigator: Andrew Limper, MD
  • Missouri
    • Hannibal, Missouri, United States, 63401
      • Recruiting
      • Hannibal Regional Healthcare System, Inc.
      • Principal Investigator: Humam Farah, MD
      • Contact: Humam Farah, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Maria Padilla, MD
      • Contact: Maria Padilla
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: Claire McGroder
      • Principal Investigator: Claire McGroder, MD
  • North Carolina
    • Statesville, North Carolina, United States, 28625
      • Recruiting
      • Piedmont HealthCare, PA
      • Contact: Jose Perez
      • Principal Investigator: Jose Perez, MD
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Southeastern Research Center
      • Principal Investigator: Jason Thomason, MD
      • Contact: Jason Thomason; Phone Number: 336-765-0383
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati
      • Principal Investigator: Nishant Gupta, MD
      • Contact: Nishant Gupta
    • Kansas, Ohio, United States, 66160
      • Recruiting
      • The University of Kansas Medical Center
      • Principal Investigator: Mark Hamblin, MD
      • Contact: Mark Hamblin
  • Oregon
    • Bend, Oregon, United States, 97701
      • Recruiting
      • Summit Health
      • Principal Investigator: Jeremy Feldman, MD
      • Contact: Jeremy Feldman, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University Hospital
      • Principal Investigator: Gerard Criner, MD
      • Contact: Gerard Criner, MD
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Principal Investigator: Ross Summer, MD
      • Contact: Ross Summer
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Timothy Whelan, MD
      • Contact: Timothy Whelan
    • Charleston, South Carolina, United States, 29406
      • Recruiting
      • Lowcountry Lung and Critical Care, PA
      • Contact: Thomas Kaelin, Jr, DO
      • Principal Investigator: Thomas Kaelin, Jr., DO
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Recruiting
      • Vanderbilt University Medical Center
      • Principal Investigator: Justin Hewlett, MD
      • Contact: Justin Hewlett, MD
  • Texas
    • El Paso, Texas, United States, 79902
      • Recruiting
      • El Paso Pulmonary Association, P.A.
      • Principal Investigator: Carlo Hatem, MD
      • Contact: Carlo Hatem, MD
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Medical Center
      • Principal Investigator: Peter Crossno, MD
      • Contact: Peter Crossno, MD
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Healthcare
      • Principal Investigator: Vikramjit Khangoora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).	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

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.	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.	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).	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

• Sponsor: Avalyn Pharma Inc.
• Investigators: Study Director: Avalyn Pharma, Inc., Avalyn Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID 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
• product manufactured in and exported from the U.S.: No