An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
NCT ID: NCT06951217
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
340 participants
INTERVENTIONAL
2025-04-17
2031-12-31
Brief Summary
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All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System for until such a time that the drug is approved, the participant withdraws from the study, or the study is terminated.
New patients will be trained to use the nebuliser at the first treatment visit. All patients will use the eFlow nebuliser to administer AP01. Hands on training for use and cleaning of the eFlow nebuliser will be performed by site personnel with patients using the study specific instructions for use and quick reference guide provided. The first treatment for new patients will be overseen by clinic personnel.
A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label AP01 treatment arm
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.
AP01
AP01 will be administered open-label via the eFlow Nebulizer System
Interventions
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AP01
AP01 will be administered open-label via the eFlow Nebulizer System
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Avalyn Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
Renstar Medical Research
Ocala, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Columbia University
New York, New York, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The University of Kansas Medical Center
Kansas, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Westmead Hospital
Westmead, New South Wales, 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
CIC Mauricie
Trois-Rivières, Quebec, Canada
Centre for Lung Health
Vancouver, Vancouver, Canada
Fakultni Thomayerove nemocnice
Praha Klanovice, , Czechia
St Antonius Hospital
Nieuwegein, , Netherlands
Greenlane Clinical Centre
Auckland, Auckland, New Zealand
Waikato Hospital
Hamilton, , New Zealand
Hospital Gregorio Marañon
Madrid, Madrid, Spain
Leicester Biomedical Research Centre
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Joyce Lee
Role: primary
Raj Karunakara
Role: primary
Andrew Limper
Role: primary
Sam Nascak
Role: backup
Claire McGroder
Role: primary
Jason Thomason
Role: primary
Nishant Gupta
Role: primary
Mark Hamblin
Role: primary
Ross Summer
Role: primary
Timothy Whelan
Role: primary
Ian Glaspole
Role: primary
Donald Lee
Role: primary
George Philteos
Role: primary
Emilie Millaire
Role: primary
Daniel Marinescu
Role: primary
Luis Puente Maestu
Role: primary
Other Identifiers
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ACTRN12625000246482
Identifier Type: REGISTRY
Identifier Source: secondary_id
AP-LTE-008
Identifier Type: -
Identifier Source: org_study_id
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