Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Assiut University
30 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
Summary
This randomized controlled trial evaluates the therapeutic role of azithromycin in acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). Baseline severity classification and stratification were performed using the SCALE-IPF framework (Severity Classification and Lung Evaluation for Prognosis in IPF; locked April 2023) to ensure balanced disease severity across randomized arms. End-of-study analyses included descriptive and stratified phenotyping using the IPIM (Idiopathic Pulmonary Fibrosis Phenotypes Identification Model; locked April 2023). Both frameworks were developed within the Assiut University IPF Research Program (2022-2026), a coordinated institutional effort investigating clinical, prognostic, and therapeutic dimensions of IPF. Neither framework altered randomization procedures, treatment allocation, or study endpoints; they were applied to improve standardization, reproducibility, and interpretability of results.
Eligibility
Inclusion Criteria2
- Baseline disease severity classified as mild or early-moderate according to the SCALE-IPF (locked April 2023) threshold ≤ 13 points.
- Participation within the Assiut University IPF Research Program (2022-2026).
Exclusion Criteria5
- Age: less than 18 years.
- Patients with any severity other than mild or early-moderate acute exacerbation of IPF according to SCALE-IPF (locked April 2023).
- Patients with multislice computed tomography with a radiological pattern rather than usual interstitial pneumonitis (UIP).
- Unstable patients need mechanical ventilation or Respiratory Intensive Care Unit admission.
- Patients with end-organ failure.
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Interventions
A single daily oral dose of Azithromycin tablet 500 mg for five days
methylprednisolone 500 mg single intra-venous daily dose for three days
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05842681