Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Cairo University (CU)

Status

Not yet enrolling

Conditions

Asbestosis

Treatments

Drug: Pirfenidone

Study type

Interventional

Funder types

Other

Identifiers

NCT05133453

Pirfenidone in asbestosis

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.