Evaluating Azithromycin and Pirfenidone Treatments for Adults With Mild to Moderate Acute Exacerbation of Idiopathic Pulmonary Fibrosis

What this Trial Is About

Researchers are evaluating the therapeutic role of azithromycin in treating acute exacerbations of idiopathic pulmonary fibrosis AE-IPF. The trial is part of the Assiut University IPF Research Program and uses the SCALE-IPF framework to classify disease severity and the IPIM model for phenotyping patients. In September 2025, the study expanded into a multi-arm platform to also assess combination antifibrotic and immunomodulatory therapies, including pirfenidone with or without azithromycin, without changing the original study design or endpoints. Participants receive conventional treatment for AE-IPF, including pulse corticosteroids and oxygen therapy. Four study groups exist one receiving conventional therapy alone another receiving conventional therapy plus azithromycin a third receiving standard-dose pirfenidone and a fourth receiving pirfenidone combined with azithromycin. Azithromycin is given initially as a 500 mg daily dose for five days, then three times weekly during follow-up. Pirfenidone is administered orally at 801 mg three times daily according to standard dosing and safety monitoring. During the study, participants are monitored for hospital stay duration, clinical outcomes stratified by disease severity, one-year mortality, and event-free survival over 12 months. Researchers use clinical, functional, and radiological assessments based on the SCALE-IPF and IPIM frameworks to evaluate treatment effects. Safety monitoring and standard clinical evaluations occur throughout the follow-up period, which includes up to one year post-randomization.

Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis