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Actively Recruiting
This research focuses on people with progressive pulmonary fibrosis or idiopathic pulmonary fibrosis (IPF) who have already completed a previous Avalyn Pharma study involving an inhaled antifibrotic medication, such as AP01. The trial aims to evaluate the long-term safety and tolerability of Avalyn's inhaled antifibrotic drug over an average of 6 years. It is an open-label extension study where all participants continue receiving treatment after their initial study completion. Participants will receive 100 mg of pirfenidone inhalation solution (AP01) twice daily through the eFlow Nebulizer System. The study includes a Screening/Baseline Visit, an open-label Treatment Period where the study drug is administered, and a Follow-up/End of Study phone call about two weeks after the last dose. Participants will start this extension on the same day they complete their previous study's final dose. During the study, adherence will be tracked using a paper dosing diary and by collecting any unused medication. Assessments include safety and tolerability monitoring throughout the long-term treatment period. The total participation lasts through the end of the study, with follow-up calls to evaluate ongoing safety after treatment ends.