Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

NCT05133453 | Not Yet Recruiting

• 1 other identifier: Pirfenidone in asbestosis
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asbestosis

Keywords

Pirfenidone; Asbestosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Pirfinedone group

ACTIVE COMPARATOR

asbestosis patients given pirfenidone drug

Drug: Pirfenidone

Conventional group

NO INTERVENTION

Asbestosis patients on conventional treatment

Interventions

Pirfenidone DRUG

drug intake three times daily for one year

Also known as: Conventional treatment

Pirfinedone group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 33798455 RESULT

MeSH Terms

Conditions

Asbestosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Study Officials

• Marwa M Fouad, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa M Fouad, MD

CONTACT

01004531905; marwa.fouad@kasralainy.edu.eg

Mohammed Elbatanouny, MD

CONTACT

01222174324; elbatanounym@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Occupational and environmental Medicine

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share