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])
Avalyn Pharma Inc.
Summary
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.
Description
All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System. The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug. A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- Combination ProductAP01
AP01 will be administered open-label via the eFlow Nebulizer System
Locations (52)
- University of Alabama at BirminghamBirmingham, Alabama
- University of Southern CaliforniaLos Angeles, California
- University of Colorado, Anschutz Medical CampusAurora, Colorado
- Renstar Medical ResearchOcala, Florida
- Piedmont Healthcare, Inc.Atlanta, Georgia
- University of MarylandBaltimore, Maryland