Extension of inhaled antifibrotic treatment with AP01 for pulmonary fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• Newport Native MD, Inc.
  Newport Beach, California, United States Recruiting
• University of Colorado, Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• UConn Health
  Farmington, Connecticut, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting

+42 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Dr. Felix Woodhead, MB BChir,PhD
• Email: fwoodhead@avalynpharma.com
• Phone: +44 7999 885973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.