RECRUITINGPhase 2INTERVENTIONAL
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
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])
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form 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.
Who Should NOT Join This Trial:
- 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
COMBINATION_PRODUCT
AP01
AP01 will be administered open-label via the eFlow Nebulizer System
Locations (20)
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
Renstar Medical Research
Ocala, Florida, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
Piedmont HealthCare, PA
Statesville, North Carolina, 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
Summit Health
Bend, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
El Paso Pulmonary Association, P.A.
El Paso, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Westmead Hospital
Westmead, New South Wales, Australia