A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF
Avalyn Pharma Inc.
Summary
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
Description
This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant meets criteria for PPF, as follows: * In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as: Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator): 1. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments 2. Relati…
Interventions
- DrugAP01
Oral inhalation solution
- OtherPlacebo
Placebo oral inhalation solution
Locations (152)
- University of Alabama at BirminghamBirmingham, Alabama
- Mayo Clinic- ScottsdaleScottsdale, Arizona
- University of Southern CaliforniaLos Angeles, California
- Cedars-SinaiLos Angeles, California
- UCLALos Angeles, California
- Newport Native MD, Inc.Newport Beach, California