Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Assiut University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Hospital stay
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Conventional therapy group
Patients will receive conventional treatment for acute exacerbation of IPF, including pulse corticosteroid therapy and supportive treatment, and oxygen therapy.
Intervention: Methylprednisolone (Drug)
Add-on Azithromycin
Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days
Intervention: Azithromycin (Drug)
Add-on Azithromycin
Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days
Intervention: Methylprednisolone (Drug)
Outcomes
Primary Outcomes
Hospital stay
Time Frame: 5-10 Days ( Days of Hospital admission until improvement and discharge)
the main aim of the study to assess the hospital stay expressed in days in the Add-on Azithromycin 500 mg single oral daily dose in comparison to the conventional therapy group only
Secondary Outcomes
- Change in clinical outcome measures stratified by SCALE-IPF severity(From randomization (Day 1) to Month 3 post-enrollment.)
- Association between SCALE-IPF severity and one-year mortality(Baseline to 12 months post-randomization.)
- Correlation between azithromycin response and IPIM phenotypic clusters(Baseline to 12 months post-randomization.)
- Event-free survival across SCALE-IPF strata(Baseline to 12 months post-randomization.)
Investigators
Ahmad Shaddad
Lecturer of pulmonary medicine Assuit university
Assiut University