RecruitingPhase 2NCT06951217

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


Sponsor

Avalyn Pharma Inc.

Enrollment

340 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying AP01 for people with idiopathic pulmonary fibrosis (ipf) and progressive pulmonary fibrosis. The study is currently recruiting participants at 54 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTAP01

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


Locations(72)

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

University of Washington

Seattle, Washington, United States

Investigaciones En Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Fundación Respirar

Buenos Aires, Argentina

Clinica Monte Grande

Buenos Aires, Argentina

Instituto Ave Pulmo, Fundacion Enfisema

Buenos Aires, Argentina

Centro Respiratorio Quilmes

Buenos Aires, Argentina

CINME

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Macquarie University Clinical Trials Unit

Macquarie Park, New South Wales, Australia

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06951217


Related Trials