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

Assiut University

Status: Enrolling

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Methylprednisolone; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05842681

2516771716

Details and patient eligibility

About

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.

Full description

This randomized, open-label controlled trial forms part of the Assiut University IPF Research Program (2022-2026). An initial target of 130 patients with clinically mild or early-moderate acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) was specified for enrollment and randomized to receive standard therapy with or without azithromycin.

SCALE-IPF (Severity Classification and Lung Evaluation for Prognosis in IPF; locked April 2023, archived November 2025, digital object identifier [DOI] 10.5281/zenodo.17575973) served as the prespecified baseline severity classification and stratification framework. IPIM (Idiopathic Pulmonary Fibrosis Phenotypes Identification Model; locked April 2023, archived November 2025, DOI 10.5281/zenodo.17576160) was applied as a predefined phenotypic framework integrating clinical, functional, and radiological domains.

Severity and phenotypic frameworks were used exclusively to define eligibility and baseline characterization. They did not influence randomization procedures, treatment allocation, trial conduct, or study endpoints, and were applied to support reproducibility and structured interpretation of therapeutic effects across severity and phenotypic spectra.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Conventional therapy group

Active Comparator group

Description:

Patients will receive conventional treatment for acute exacerbation of IPF, including pulse corticosteroid therapy and supportive treatment, and oxygen therapy.

Treatment:

Drug: Methylprednisolone

Add-on Azithromycin

Active Comparator group

Description:

Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days

Treatment:

Drug: Azithromycin

Drug: Methylprednisolone