Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Not Applicable

Not yet recruiting

• Conditions: Asbestosis
• Interventions: Drug: Pirfenidone

• Registration Number: NCT05133453
• Lead Sponsor: Cairo University

Brief Summary

This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.

Detailed Description

Asbestos exposure is associated with pleural and lung fibrosis and lung cancer. It has pathomechanisms and clinical similarities to interstitial pulmonary fibrosis disease. There is no definite cure for asbestosis. Pirfenidone has antifibrotic and anti-inflammatory effects.The safety and effectiveness of pirfenidone for the treatment of non-interstitial pulmonary fibrosis progressive fibrotic interstitial lung diseases remain unclear including asbestosis. Only few studies for pirfenidone use in asbestosis.

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Study Start: 2024-02
• Primary Completion: 2025-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Male patients aged ≥ 18 years old
• Patients who fulfilled investigations according the study protocol.
• Patients who kept on follow up for the entire study.
• All patients fulfilling the clinical and radiological criteria of asbestosis (Existence of asbestos-specific pleural changes in high resolution computed topography HRCT (pleural plaques), Reticular changes in HRCT and restrictive lung function pattern, History of asbestos exposure, Absence of an alternative explanation for fibrotic lung disease )
• Clinically stable patients.
• Patients who signed informed consent
• Patients with mild-to-moderate IPF [forced vita capacity (FVC) ≥50% of predicted and diffusion capacity of carbon monoxide (DLCO) ≥30% of predicted].
• Duration since diagnosis (at least one year before the study)

Exclusion Criteria

• Patients with peptic ulcer,
• Severe hepatic disease, hepatitis C infection or any of the following liver function test criteria above specified limits: aspartate or alanine aminotransferase (AST or ALT) >2.5 u above upper limit of normal level.
• Severe kidney disease, Cardiac disease, and Patients with other chronic pulmonary diseases, lung cancer
• Presence of coexisting respiratory infection
• History of alcohol or drugs abuse
• Patients with neuromuscular disease,
• Chronic renal failure,
• Patient on oxygen therapy,
• Life expectancy less than 6 months,
• History of malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirfinedone group	Pirfenidone	asbestosis patients given pirfenidone drug

Primary Outcome Measures

Name	Time	Method
radiological findings change	after 6 months and 12 months from the start of the trial	radiological changes in High resolution computed topography.
Ventilatory function change	after 6 months and 12 months from the start of the trial	Absolute change in percent predicted forced vital capacity
Diffusion test	after 6 months and 12 months from the start of the trial	Diffusion test change from baseline