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An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Sponsor: Avalyn Pharma Inc.
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 the same day.
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])
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2025-04-17
Completion Date
2031-12-31
Last Updated
2026-08-07
Healthy Volunteers
No
Interventions
AP01
AP01 will be administered open-label via the eFlow Nebulizer System
Locations (68)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
Renstar Medical Research
Ocala, Florida, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
Piedmont HealthCare, PA
Statesville, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Summit Health
Bend, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
El Paso Pulmonary Association, P.A.
El Paso, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Inova Healthcare
Falls Church, Virginia, United States
Investigaciones En Patologias Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Fundación Respirar
Buenos Aires, Argentina
Instituto Ave Pulmo, Fundacion Enfisema
Buenos Aires, Argentina
CINME
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Westmead Hospital
Westmead, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
The Prince Charles Hospital (TPCH)
Chermside, Australia
Lung & Sleep Victoria
Footscray, Australia
Respiratory Clinical Trials PTY Ltd
Kent Town, Australia
Nepean Lung & Sleep
Kingston, Australia
Univ of Western Australia / Institute for Respiratory Health
Nedlands, Australia
John Hunter Hospital
New Lambton Heights, Australia
Dynamic Drug Advancement
Ajax, Ontario, Canada
Research Institute McGill University Health Center
Montreal, Quebec, Canada
CIC Mauricie
Trois-Rivières, Quebec, Canada
Centre for Lung Health
Vancouver, Vancouver, Canada
Fakultni Thomayerove nemocnice
Praha Klanovice, Czechia
University of Montpellier
Montrevel-en-Bresse, Montpellier, France
Centre Hospitalier Universitaire d'Angers
Angers, France
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Studienzentrum Dr. Claus Keller
Frankfurt, Germany
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
Pavia, Lombardy, Italy
HUMANITAS Research Hospital
Milan, Italy
Ospedale San Giuseppe/ MultiMedica SPA
Milan, Italy
St Antonius Hospital
Nieuwegein, Netherlands
Greenlane Clinical Centre
Auckland, Auckland, New Zealand
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Bay of Plenty Clinical Trials Unit
Tauranga, Tauranga, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Department of Pneumology of the University Hospital No 1
Lodz, Poland
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Gregorio Marañon
Madrid, Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hull University Teaching Hospital
Cottingham, East Yorkshire, United Kingdom
ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
Birmingham, West Midlands, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Leicester Biomedical Research Centre
Leicester, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom