Print Send My Information

Purpose

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day. 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Combination Product: AP01
    AP01 will be administered open-label via the eFlow Nebulizer System

Recruiting Locations

University of Colorado, Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Contact:
Joyce Lee
000-000-000

Renstar Medical Research
Ocala 4166673, Florida 4155751 34470
Contact:
Raj Karunakara

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55901
Contact:
Andrew Limper
000-000-000

Columbia University
New York 5128581, New York 5128638 10032
Contact:
Claire McGroder
000-000-000

Southeastern Research Center
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
Jason Thomason
336-765-0383

University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45267
Contact:
Nishant Gupta
000-000-000

The University of Kansas Medical Center
Kansas 5159405, Ohio 5165418 66160
Contact:
Mark Hamblin
000-000-000

Thomas Jefferson University
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Ross Summer
000-000-000

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Timothy Whelan
000-000-000

More Details

NCT ID
NCT06951217
Status
Recruiting
Sponsor
Avalyn Pharma Inc.

Study Contact

Dr. Felix Woodhead, MA, MB, BChir, FRCP, PhD
+44 7999 885973
fwoodhead@avalynpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center