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Extension of inhaled antifibrotic treatment with AP01 for pulmonary fibrosis

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])

Phase 2 Interventional Avalyn Pharma Inc. · NCT06951217

This open-label extension lets people with progressive pulmonary fibrosis or IPF who finished a prior Avalyn inhaled-drug study continue taking inhaled pirfenidone (AP01) twice daily to see if they can tolerate and stay on treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years and up
SexAll
SponsorAvalyn Pharma Inc. Industry-sponsored
Locations52 sites (Birmingham, Alabama and 51 other locations)
Trial IDNCT06951217 on ClinicalTrials.gov

What this trial studies

This open-label extension enrolls participants who completed an Avalyn-sponsored inhaled-antifibrotic lead-in study and received the full-dose treatment. Participants will inhale 100 mg pirfenidone solution (AP01) twice daily using the eFlow Nebulizer System during the treatment period. Study procedures include a screening/baseline visit, the open-label treatment period with adherence monitored by a paper dosing diary and return of unused drug, and an end-of-study follow-up phone call about two weeks after the last dose. The extension is intended to continue exposure to AP01 and collect additional safety and tolerability data, with IPF enrollment limited outside the US and Canada per the lead-in criteria.

Who should consider this trial

Good fit: Adults with progressive pulmonary fibrosis (and IPF patients outside the US/Canada) who completed the full-dose treatment period of an Avalyn inhaled-antifibrotic lead-in study and have the Study Physician's approval are ideal candidates.

Not a fit: People who did not participate in the prior Avalyn lead-in study, cannot use the eFlow nebulizer, or have contraindications to pirfenidone are unlikely to benefit from this extension.

Why it matters

Potential benefit: If successful, continued AP01 dosing could provide ongoing access to the inhaled medication and offer additional information about tolerability and longer-term use that might help maintain lung function.

How similar studies have performed: Inhaled pirfenidone formulations have been tested in earlier-phase trials showing acceptable tolerability and promising pharmacologic targeting, but large-scale efficacy data remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

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:

* 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.

Where this trial is running

Birmingham, Alabama and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Progressive Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.