Actively Recruiting
Long-Term Safety and Tolerability Open-Label Extension Study of Avalyn Inhaled Antifibrotic Agents for Pulmonary Fibrosis
Led by Avalyn Pharma Inc. · Updated on 2026-04-29
340
Participants Needed
52
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on participants with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously taken part in Avalyn Pharma-sponsored studies involving an inhaled antifibrotic medication called AP01. The study aims to evaluate the long-term safety and tolerability of this inhaled antifibrotic treatment over an average duration of six years in an open-label extension design. All participants will receive 100 mg of inhaled pirfenidone solution (AP01) twice daily using the eFlow Nebulizer System. The study includes a Screening/Baseline Visit, an open-label Treatment Period where participants continue using AP01 from their initial study, and a follow-up phone call approximately two weeks after their last dose. Participants will use a paper diary to record dosing adherence and return any unused medication. During the study, researchers will assess safety and tolerability, lung function changes measured by forced vital capacity (FVC), disease stabilization, and quality of life reported by participants. The total participation time averages six years, including monitoring through regular visits and a final follow-up call. Adherence tracking and safety assessments are integral parts of the study to understand the long-term effects of the inhaled antifibrotic therapy.
CONDITIONS
Brief Title
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) with physician approval
- Completed the final visit of the Treatment Period on the full dose of study drug (active or placebo)
- Male subjects and female subjects of childbearing potential agree to use highly effective contraception during the study and for 90 days after last dose
- Agree not to donate eggs or sperm during the study and 90 days after last dose
You will not qualify if you...
- Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study
- Were permanently discontinued from the lead-in study for any reason or discontinued study drug but continued visits
- Experienced asthma or COPD exacerbation requiring corticosteroids within 3 months before screening
- Experienced acute exacerbation of IPF or PPF within 3 months before screening
- Participated in another investigational drug study within 30 days or 5 half-lives before screening (except Avalyn nebulized antifibrotic)
- History of allergic reaction or hypersensitivity to pirfenidone or its excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Average of 6 years
Participants receive 100 mg inhaled pirfenidone inhalation solution (AP01) twice daily using the eFlow Nebulizer System to evaluate long-term safety and tolerability.
Visits scheduled as per study protocol during treatment period
Duration - Approximately 2 weeks
Participants complete an end of study follow-up phone call approximately 2 weeks after their last dose to assess safety and tolerability.
1 follow-up phone call
Trial Site Locations
Total: 52 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Renstar Medical Research
Ocala, Florida, United States, 34470
Actively Recruiting
5
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States, 30309
Actively Recruiting
6
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55901
Actively Recruiting
8
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri, United States, 63401
Actively Recruiting
9
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
10
Columbia University
New York, New York, United States, 10032
Actively Recruiting
11
Piedmont HealthCare, PA
Statesville, North Carolina, United States, 28625
Actively Recruiting
12
Southeastern Research Center
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
13
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
14
The University of Kansas Medical Center
Kansas, Ohio, United States, 66160
Actively Recruiting
15
Summit Health
Bend, Oregon, United States, 97701
Actively Recruiting
16
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
17
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
18
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, United States, 29406
Actively Recruiting
19
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
20
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37204
Actively Recruiting
21
El Paso Pulmonary Association, P.A.
El Paso, Texas, United States, 79902
Actively Recruiting
22
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
23
Inova Healthcare
Falls Church, Virginia, United States, 22042
Actively Recruiting
24
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
25
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Active, Not Recruiting
26
Royal Prince Alfred Hospital
Camperdown, Australia
Actively Recruiting
27
The Prince Charles Hospital (TPCH)
Chermside, Australia
Actively Recruiting
28
Lung & Sleep Victoria
Footscray, Australia
Actively Recruiting
29
Respiratory Clinical Trials PTY Ltd
Kent Town, Australia
Actively Recruiting
30
Nepean Lung & Sleep
Kingston, Australia
Actively Recruiting
31
Univ of Western Australia / Institute for Respiratory Health
Nedlands, Australia
Actively Recruiting
32
John Hunter Hospital
New Lambton Heights, Australia
Actively Recruiting
33
Dynamic Drug Advancement
Ajax, Ontario, Canada
Actively Recruiting
34
Research Institute McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
35
CIC Mauricie
Trois-Rivières, Quebec, Canada, G8T 7A1
Actively Recruiting
36
Centre for Lung Health
Vancouver, Canada, V5Z1M9
Actively Recruiting
37
Fakultni Thomayerove nemocnice
Praha Klanovice, Czechia
Actively Recruiting
38
University of Montpellier
Montrevel-en-Bresse, Montpellier, France, 34090
Actively Recruiting
39
Centre Hospitalier Universitaire d'Angers
Angers, France, 49933
Actively Recruiting
40
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
41
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
Pavia, Lombardy, Italy, 27100
Actively Recruiting
42
St Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
43
Greenlane Clinical Centre
Auckland, New Zealand
Actively Recruiting
44
Dunedin Hospital
Dunedin, New Zealand, 9016
Active, Not Recruiting
45
Waikato Hospital
Hamilton, New Zealand
Actively Recruiting
46
Bay of Plenty Clinical Trials Unit
Tauranga, New Zealand, 3112
Actively Recruiting
47
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80211
Actively Recruiting
48
Department of Pneumology of the University Hospital No 1
Lodz, Poland, 90315
Actively Recruiting
49
Hospital Gregorio Marañon
Madrid, Spain
Actively Recruiting
50
Hull University Teaching Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Actively Recruiting
51
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
52
Leicester Biomedical Research Centre
Leicester, United Kingdom
Actively Recruiting
Research Team
D
Dr. Felix Woodhead, MB BChir,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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