Study Overview: This study is for people who finished a previous Avalyn Pharma study with a special medicine called an "inhaled antifibrotic" like AP01. The new study is called an "extension study," which means it continues the research. Participants will receive 100 mg of pirfenidone inhalation solution (AP01) twice daily using a device called the eFlow Nebulizer System.
Study Process: There are three main parts: a Screening/Baseline Visit to start, an open-label Treatment Period where you continue taking the medicine, and a Follow-up/End of Study phone call about two weeks after the last medicine dose. You'll need to keep a paper diary to track your doses and return any unused medicine.
Key Points:
- Length and Visits: The study includes a few visits and a follow-up call.
- Participation: You must have completed a previous study with Avalyn to join.
- Contraception and Safety: Participants should use effective birth control during the study and for 90 days after it ends.
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