Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Asbestosis
• Intervention / Treatment: Drug: Pirfenidone

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa M Fouad, MD; Phone Number: 01004531905; Email: marwa.fouad@kasralainy.edu.eg
• Study Contact Backup: Name: Mohammed Elbatanouny, MD; Phone Number: 01222174324; Email: elbatanounym@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pirfinedone group; asbestosis patients given pirfenidone drug	Drug: Pirfenidone; drug intake three times daily for one year; Other Names: Conventional treatment
No Intervention: Conventional group; Asbestosis patients on conventional treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Marwa M Fouad, MD, Cairo University

Publications and helpful links

General Publications

• Behr J, Prasse A, Kreuter M, Johow J, Rabe KF, Bonella F, Bonnet R, Grohe C, Held M, Wilkens H, Hammerl P, Koschel D, Blaas S, Wirtz H, Ficker JH, Neumeister W, Schonfeld N, Claussen M, Kneidinger N, Frankenberger M, Hummler S, Kahn N, Tello S, Freise J, Welte T, Neuser P, Gunther A; RELIEF investigators. Pirfenidone in patients with progressive fibrotic interstitial lung diseases other than idiopathic pulmonary fibrosis (RELIEF): a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Respir Med. 2021 May;9(5):476-486. doi: 10.1016/S2213-2600(20)30554-3. Epub 2021 Mar 30.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pirfenidone; Asbestosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Pneumoconiosis; Lung Diseases, Interstitial; Lung Injury; Asbestosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: Pirfenidone in asbestosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No