Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Asbestosis Clinical Trial

Official title:

Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05133453
• Other study ID #: Pirfenidone in asbestosis
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: February 2026

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Marwa M Fouad, MD
• Phone: 01004531905
• Email: marwa.fouad[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asbestosis

Intervention

Drug:
• Pirfenidone
drug intake three times daily for one year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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, — View Citation

Outcome

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