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Extension Study of Avalyn Inhaled Antifibrotic Agent (AP01) for Pulmonary Fibrosis

This study is an extension for people who have already participated in an Avalyn-sponsored clinical study involving an inhaled antifibrotic medication. It aims to evaluate the long-term safety and how well people tolerate Avalyn's AP01, an inhaled pirfenidone solution, when used for conditions like Progressive Pulmonary Fibrosis or Idiopathic Pulmonary Fibrosis (IPF). You would receive AP01 twice daily using an eFlow Nebulizer System. The study plans to enroll 340 participants, and its current status is unclear. Success for this study will be measured by tracking safety and tolerability over an average of 6 years.

Study design
This is an open-label extension study, meaning everyone knows they are receiving the active treatment. It plans to enroll 340 participants.
What's involved
You would have a Screening/Baseline Visit, an open-label Treatment Period where you take AP01 twice daily, and a follow-up phone call about two weeks after your last dose.
Compensation
Not stated in the trial record.
Follow-up
You will have a follow-up phone call approximately 2 weeks after your last dose of study drug. The primary endpoint for safety and tolerability is measured through the end of the study, an average of 6 years.

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NCT06951217

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Avalyn Pharma Inc.
~340 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AP01

At a glance

Recruiting sites
70 of 72 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).
Measured over Through end of study; average of 6 years

Conditions

Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

Explore related trials

Idiopathic Pulmonary FibrosisPulmonary Fibrosis

Where it's being run

72 sites across 47 states
Australia7
Argentina6
United Kingdom3
Maryland2
New York2
North Carolina2
Pennsylvania2
South Carolina2

Study leadership

  • Avalyn Pharma, Inc. · STUDY_DIRECTOR · Avalyn Pharma Inc.

Who to contact

Dr. Felix Woodhead, MB BChir,PhD
[email protected]
+44 7999 885973
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.
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

Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
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.

What this trial measures

  • To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).Through end of study; average of 6 years

    The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), oxygen saturation, spirometry, physical exams, blood chemistry, and quality of life assessments.