Progressive Pulmonary FibrosisPhase 2SAILNCT06951217
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
A Phase 2 study testing AP01 in people with Progressive Pulmonary Fibrosis and Idiopathic Pulmonary Fibrosis (IPF), run by Avalyn Pharma Inc. at 92 sites in 13 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- AP01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 92 sitesin 13 countries
- Study dates
- 17 Apr 2025to 31 Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
92 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
92 sites in 13 countries
United States32 sites, 32 recruiting
- Recruiting
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30309
Amy Case, amy.case@piedmont.org
Amy Case, MD
- Recruiting
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
Joyce Lee, joyce.lee@cuanschutz.edu
Joyce Lee, MD
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
ebritt@som.umaryland.edu
Edward Britt
- Recruiting
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21205
mlammi2@jh.edu
Matthew Lammi, MD
- Recruiting
Summit Health
Bend, Oregon, 97701
Jeremy Feldman, jfeldman@summithealth.com
Jeremy Feldman, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Tejaswini Kulkarni, tanzira.zaman@cshs.org
Tejaswini Kulkarni
- Recruiting
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, 29406
Thomas Kaelin, Jr, tkaelin@lowcountrylung.com
Thomas Kaelin, Jr., DO
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Timothy Whelan, whelant@musc.edu
Timothy Whelan, MD
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Nishant Gupta, guptans@ucmail.us.edu
Nishant Gupta, MD
- Recruiting
El Paso Pulmonary Association, P.A.
El Paso, Texas, 79902
Carlo Hatem, MD, carlo.hatem@elligodirect.com
Carlo Hatem, MD
- Recruiting
Inova Healthcare
Falls Church, Virginia, 22042
vikramjit.khangoora@inova.org
Vikramjit Khangoora
- Recruiting
UConn Health
Farmington, Connecticut, 06030
Ameer Rasheed
Ameer Rasheed
- Recruiting
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri, 63401
Humam Farah, humam.farah@hannibalclinic.com
Humam Farah, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Ivan Rosas, ivan.rosas@bcm.edu
Ivan Rosas
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Mark Hamblin, mhamblin@kumc.edu
Mark Hamblin
- Recruiting
University of Southern California
Los Angeles, California, 90033
Toby Maher, toby.maher@med.usc.edu
Toby Maher
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Peter Crossno, peter.crossno@imail.org
Peter Crossno, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Justin Hewlett, MD, justin.c.hewlett@vumc.org
Justin Hewlett, MD
- Recruiting
Yale University
New Haven, Connecticut, 06519
Mridu Gulati, mridu.gulati@yale.edu
Mridu Gulati
- Recruiting
Weill Cornell
New York, New York, 10021
Anna Podolanczuk, ajp9012@med.cornell.edu
Anna Podolanczuk
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Maria Padilla, maria.padilla@mountsinai.org
Maria Padilla, MD
- Recruiting
Columbia University
New York, New York, 10032
Claire McGroder, cm3485@cumc.columbia.edu
Claire McGroder, MD
- Recruiting
Newport Native MD, Inc.
Newport Beach, California, 92663
Ryan Klein, ryan@newportnativemd.com
Ryan Klein
- Recruiting
Renstar Medical Research
Ocala, Florida, 34470
Raj Karunakara, raj.karunakara@renstar.net
Raj Karunakara, MD
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Ross Summer, ross.summer@jefferson.edu
Ross Summer, MD
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Gerard Criner, gerard.criner@tuhs.temple.edu
Gerard Criner, MD
- Recruiting
The Oregon Clinic Pulmonary East
Portland, Oregon, 97220
David Hotchkin, dhotchkin@orclinic.com
David Hotchkin
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Andrew Limper, limper.andrew@mayo.edu
Sam Nascak
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
mary.beth.scholand@hsc.utah.edu
Mary Beth Scholand, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Suha Kadura, skadura@uw.edu
Suha Kadura
- Recruiting
Piedmont HealthCare, PA
Statesville, North Carolina, 28625
Jose Perez, jose.perez@piedmonthealthcare.com
Jose Perez, MD
- Recruiting
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Jason Thomason, jthomason@southeasternresearchcenter.com
Jason Thomason, MD
Australia12 sites, 11 recruiting
- Recruiting
Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
Brisbane, Queensland, 4032
Daniel Chambers, dan@lrq.com.au
Daniel Chambers
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Tamera Corte, tamera.corte@health.nsw.gov.au
Tamera Corte
- Recruiting
The Prince Charles Hospital (TPCH)
Chermside
Peter Hopkins, peter_hopkins@health.qld.gov.au
Peter Hopkins
- Recruiting
Lung & Sleep Victoria
Footscray
Ian Glaspole, iglaspole@lasv.com.au
Ian Glaspole
- Recruiting
Respiratory Clinical Trials PTY Ltd
Kent Town
Michael Chia, mmchia@hotmail.com
Michael Chia
- Recruiting
Nepean Lung & Sleep
Kingston
Donald Lee, donald.lee@nepeanlungandsleep.com.au
Donald Lee
- Recruiting
Macquarie University Clinical Trials Unit
Macquarie Park, New South Wales, 2113
Elizabeth Veitch, elizabeth.veitch@health.nsw.gov.au
Elizabeth Veitch
- Recruiting
Alfred Health
Melbourne, Victoria, 3004
Jun Keng Khoo, j.khoo2@alfred.org.au
Jun Keng Khoo
- Recruiting
Univ of Western Australia / Institute for Respiratory Health
Nedlands
Vidya Navaratnam, Vidya.Navaratnam@health.wa.gov.au
Vidya Navaratnam
- Recruiting
John Hunter Hospital
New Lambton Heights
Christopher Grainge, christopher.grainge@health.nsw.gov.au
Christopher Grainge
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Jimmy Chien, jimmy.chien@sydney.edu.au
Jimmy Chien
- Active, not recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
United Kingdom10 sites, 10 recruiting
- Recruiting
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
Birmingham, West Midlands, B15 2GW
Anjali Crawshaw, anjali.crawshaw@uhb.nhs.uk
Anjali Crawshaw
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0AY
Helen Parfrey, helen.parfrey@nhs.net
Helen Parfrey
- Recruiting
Hull University Teaching Hospital
Cottingham, East Yorkshire, HU16 5JQ
Simon Hart, s.hart@hull.ac.uk
Simon Hart
- Recruiting
Royal Devon
Exeter, Devon, EX2 5DW
Michael Gibbons
Michael Gibbons
- Recruiting
St James University Hospital
Leeds, Yorkshire, LS9 7TF
Paul Beirne
- Recruiting
Leicester Biomedical Research Centre
Leicester
Charlotte Swales, Charlotte.Swales@uhl-tr.nhs.uk
Charlotte Swales
- Not yet recruiting
Royal Brompton Hospital
London, London, SW3 6NP
Peter George
Peter George
- Recruiting
St. George's University Hospitals NHS Foundation Trust
London, SW17 0RE
Aul Raminder, raminder.aul@stgeorges.nhs.uk
Aul Raminder
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, South East England, OX3 7LE
Rachel Hoyles, rachel.hoyles@ouh.nhs.uk
Rachel Hoyles
- Not yet recruiting
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
Helen Stone
Helen Stone
Argentina8 sites, 8 recruiting
- Recruiting
Fundación Respirar
Buenos Aires, 1427
Pablo Doreski, respiramos@yahoo.com.ar
Pablo Doreski
- Recruiting
Clinica Monte Grande
Buenos Aires, 1842
Xavier Bocca Ruiz, xbocca@gmail.com
- Recruiting
Instituto Ave Pulmo, Fundacion Enfisema
Buenos Aires, 7600
Luis Wehbe, lwehbe@gmail.com
Luis Wehbe
- Recruiting
Centro Respiratorio Quilmes
Buenos Aires, B1878
Marcelo Fernandez, centrorespiratorio@yahoo.com.ar
Marcelo Fernandez
- Recruiting
CINME
Buenos Aires, C1056ABI
motaola@cinme.com.ar
Maria Otaola
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABH
Joaquin Maritano Furcada, joaquin.maritano@hospitalitaliano.org.ar
Joaquin Maritano Furcada
- Recruiting
CIMER Centro Integral de Medicina Respiratoria
San Miguel de Tucumán, Tucumán Province, T4000CBC
Hector Altieri, hhaltieri@gmail.com
Hector Altieri
- Recruiting
Investigaciones En Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, T4000IAP
Ramon Angel Rojas, ipr_ramon@yahoo.com.ar
Ramon Angel Rosas
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitary de Bellvitge
Barcelona, Barcelona, 08908
Maria Molina, mariamolinamolina@hotmail.com
Maria Molina
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, 18014
Ana Dolores Romero Ortiz, anadoloresromeroortiz@gmail.com
Ana Dolores Romero Ortiz
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Juan Rigual, juanabelardo.rigual@salud.madrid.org
Juan Rigual
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Juan Rigual
- Recruiting
Hospital Gregorio Marañon
Madrid, Madrid
Luis Puente Maestu, luis.puente@salud.madrid.org
Luis Puente Maestu
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Jose Luis Velasco Garrido, jlvelascogarrido@hotmail.com
Jose Luis Velasco Garrido
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
José Cifrian, josemanuel.cifrian@scsalud.es
José Cifrian
New Zealand5 sites, 4 recruiting
- Recruiting
Greenlane Clinical Centre
Auckland, Auckland
Margaret Wilsher, mwilsher@adhb.govt.nz
Margaret Wilsher
- Recruiting
Christchurch Hospital
Christchurch, Canterbury, 8011
Michael Epton, michael.epton@cdhb.health.nz
Michael Epton
- Active, not recruiting
Dunedin Hospital
Dunedin, 9016
- Recruiting
Waikato Hospital
Hamilton
Catherina Chang, cat.chang@waikatodhb.health.nz
Catherina Chang
- Recruiting
Bay of Plenty Clinical Trials Unit
Tauranga, Tauranga, 3112
Suzanne Poole, suzanne.poole@bopdhb.govt.nz
Suzanne Poole
Canada4 sites, 4 recruiting
- Recruiting
Dynamic Drug Advancement
Ajax, Ontario
George Philteos, drphilteos.study@gmail.com
George Philteos
- Recruiting
Research Institute McGill University Health Center
Montreal, Quebec, H4A 3J1
Deborah Assayag, deborah.assayag@mcgill.ca
Deborah Assayag
- Recruiting
CIC Mauricie
Trois-Rivières, Quebec, G8T 7A1
Emilie Millaire, emillaire@cic-mauricie.ca
Emilie Millaire
- Recruiting
Centre for Lung Health
Vancouver, Vancouver, V5Z1M9
Daniel Marinescu, daniel.marinescu@vch.ca
Daniel Marinescu
Germany3 sites, 3 recruiting
- Recruiting
Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie
Berlin, State of Berlin, 12351
Sven Gläser, sven.glaeser@vivantes.de
Sven Gläser
- Recruiting
Studienzentrum Dr. Claus Keller
Frankfurt, 60389
Claus Keller, ckeller-studien@praxis-ckeller.de
Claus Keller
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Jonas Schupp, schupp.jonas@mh-hannover.de
Jonas Schupp
Italy3 sites, 3 recruiting
- Recruiting
HUMANITAS Research Hospital
Milan, 20089
Francesco Amati, francesco.amati@hunimed.eu
Francesco Amati
- Recruiting
Ospedale San Giuseppe/ MultiMedica SPA
Milan, 20123
Sergio Harari, sergio.harari@multimedica.it
Sergio Harari
- Recruiting
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
Pavia, Lombardy, 27100
Angelo Guido Corsico, corsico@unipv.it
Angelo Guido Corsico
Poland3 sites, 3 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80211
Amelia Szymanowska-Narloch, aszymanowska@gumed.edu.pl
Amelia Szymanowska-Narloch
- Recruiting
Department of Pneumology of the University Hospital No 1
Lodz, 90315
Wojciech Piotrowski, wojciech.piotrowski@umed.lodz.pl
Wojciech Piotrowski
- Recruiting
Prywatny Gabinet Lekarski Ginekologia I Połoznictwo Ultrasonografia
Lodz, Łódź Voivodeship, 90-602
Izabela Grabska-Kobylecka, grabskakobylecka@gmail.com
Izabela Grabska- Kobylecka
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Frederic Gagnadoux, fgagnadoux@chu-angers.fr
Frederick Gagnadoux
- Recruiting
University of Montpellier
Montrevel-en-Bresse, Montpellier, 34090
Arnaud Bourdin, a-bourdin@chu-montpellier.fr
Arnaud Bourdin
Netherlands2 sites, 2 recruiting
- Recruiting
St Antonius Hospital
Nieuwegein
Marcel Veltkamp, m.veltkamp@antoniusziekenhuis.nl
Marcel Veltkamp
- Recruiting
Erasmus University Medical Center
Rotterdam, 3015
Thomas Koudstaal
Thomas Koudstaal
Czechia1 site, 1 recruiting
- Recruiting
Fakultni Thomayerove nemocnice
Praha Klanovice
Martina Sterclova, martina.sterclova@ftn.cz
Martina Sterclova
About this study
Official title: 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.
Read the 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.
- Being tested
- AP01
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP01Combination product
AP01 will be administered open-label via the eFlow Nebulizer System
| Study group | Role | What they receive |
|---|---|---|
| Open-label AP01 treatment arm | Experimental | 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. Receives: Combination Product: AP01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through end of study; average of 6 years
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.'
Measured: Through end of study; average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start17 Apr 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Pulmonary FibrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avalyn Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avalyn Pharma, Inc., Study director, Avalyn Pharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951217
- Sponsor's protocol ID
- AP-LTE-008
- Other IDs
- ACTRN12625000246482
- Acronym
- SAIL
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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])
- ClinicalTrials.gov ID
- NCT06951217
- Acronym / sponsor ID
- SAIL / AP-LTE-008
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Avalyn Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label AP01 treatment arm | Experimental | Combination Product: AP01All 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| AP01AP01 will be administered open-label via the eFlow Nebulizer System | Combination product | Open-label AP01 treatment arm |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Avalyn Pharma, Inc. study director
Avalyn Pharma Inc.
92 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP01 in people with Progressive Pulmonary Fibrosis and Idiopathic Pulmonary Fibrosis (IPF), run by Avalyn Pharma Inc. at 92 sites in 13 countries.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, Australia, United Kingdom, Argentina, Spain and 8 more countries. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Felix Woodhead, MB BChir,PhD (+44 7999 885973, fwoodhead@avalynpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 Nov 2026.