Actively Recruiting
Phase 2 Randomized Study Evaluating Nintedanib Inhalation Solution AP02 for Adults with Idiopathic Pulmonary Fibrosis
Led by Avalyn Pharma Inc. · Updated on 2026-08-10
160
Participants Needed
24
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Nintedanib Solution for Inhalation AP02 on lung function and fibrosis markers in adults aged 40 and older with idiopathic pulmonary fibrosis IPF. This phase 2 study also aims to assess the safety and tolerability of AP02. Participants must not be currently receiving treatment for IPF, or must have stopped prior oral nintedanib or pirfenidone treatment for at least three months. Participants are randomly assigned to one of three groups two different doses of AP02 or a placebo inhalation solution. They will receive the assigned treatment twice daily for 12 weeks using a nebulizer to deliver the medication directly to the lungs. The study involves a total of six office visits and one phone call over 16 weeks. During these visits, doctors will perform lung function tests, including measuring forced vital capacity, administer questionnaires, and monitor participants health. The main outcome is the change in lung capacity after 12 weeks of treatment. Researchers will also evaluate disease progression and changes in lung fibrosis. Participants are closely monitored for safety and follow-up throughout the study period.
CONDITIONS
Brief Title
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Research Team
C
Craig S Conoscenti, MD, FCCP, ATSF
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