An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Start Date
4/17/2025
Completion Date
12/31/2031
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AP01
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35205
United States
University of Southern California
Los Angeles, California 90033
United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado 80045
United States
Renstar Medical Research
Ocala, Florida 34470
United States
Piedmont Healthcare, Inc.
Atlanta, Georgia 30309
United States
The University of Kansas Medical Center
Kansas City, Kansas 66160
United States
University of Maryland
Baltimore, Maryland 21201
United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland 21205
United States
Mayo Clinic Rochester
Rochester, Minnesota 55901
United States
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri 63401
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University
New York, New York 10032
United States
Piedmont HealthCare, PA
Statesville, North Carolina 28625
United States
Southeastern Research Center
Winston-Salem, North Carolina 27103
United States
University of Cincinnati
Cincinnati, Ohio 45267
United States
Summit Health
Bend, Oregon 97701
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina 29406
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37204
United States
El Paso Pulmonary Association, P.A.
El Paso, Texas 79902
United States
Intermountain Medical Center
Murray, Utah 84107
United States
University of Utah
Salt Lake City, Utah 84108
United States
Inova Healthcare
Falls Church, Virginia 22042
United States
Westmead Hospital
Westmead, New South Wales 2145
Australia
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
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 H4A 3J1
Canada
CIC Mauricie
Trois-Rivières, Quebec G8T 7A1
Canada
Centre for Lung Health
Vancouver, Vancouver V5Z1M9
Canada
Fakultni Thomayerove nemocnice
Praha Klanovice,
Czechia
University of Montpellier
Montrevel-en-Bresse, Montpellier 34090
France
Centre Hospitalier Universitaire d'Angers
Angers, 49933
France
Medizinische Hochschule Hannover
Hanover, Lower Saxony 30625
Germany
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
Pavia, Lombardy 27100
Italy
St Antonius Hospital
Nieuwegein,
Netherlands
Greenlane Clinical Centre
Auckland, Auckland
New Zealand
Bay of Plenty Clinical Trials Unit
Tauranga, Tauranga 3112
New Zealand
Dunedin Hospital
Dunedin, 9016
New Zealand
Waikato Hospital
Hamilton,
New Zealand
Uniwersyteckie Centrum Kliniczne
Gdansk, 80211
Poland
Department of Pneumology of the University Hospital No 1
Lodz, 90315
Poland
Hospital Gregorio Marañon
Madrid, Madrid
Spain
Hull University Teaching Hospital
Cottingham, East Yorkshire HU16 5JQ
United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0AY
United Kingdom
Leicester Biomedical Research Centre
Leicester,
United Kingdom