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

NCT ID: NCT05842681

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional therapy group

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

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

methylprednisolone 500 mg single intra-venous daily dose for three days

Add-on Azithromycin

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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

A single daily oral dose of Azithromycin tablet 500 mg for five days

Methylprednisolone

Intervention Type DRUG

methylprednisolone 500 mg single intra-venous daily dose for three days

Interventions

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Azithromycin

A single daily oral dose of Azithromycin tablet 500 mg for five days

Intervention Type DRUG

Methylprednisolone

methylprednisolone 500 mg single intra-venous daily dose for three days

Intervention Type DRUG

Other Intervention Names

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azithromycin 500 mg oral tablet methylprednisolone 500 mg

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Shaddad

Lecturer of pulmonary medicine Assuit university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmad M shaddad

Role: PRINCIPAL_INVESTIGATOR

Assiut university-Faculty of Medicine

Locations

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Assiut university-Faculty of Medicine

Asyut, , Egypt

Site Status RECRUITING

Faculty of Medicine Assuit University

Asyut, , Egypt

Site Status ACTIVE_NOT_RECRUITING

Countries

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Egypt

Central Contacts

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ahmad M shaddad, MD

Role: CONTACT

01111171930

Facility Contacts

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ahmad shaddad, MD

Role: primary

01111171930

Other Identifiers

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2516771716

Identifier Type: -

Identifier Source: org_study_id

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