Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

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

Detailed Description
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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.

Official Title
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Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Conditions
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Asbestosis

Intervention / Treatment
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* Drug: Pirfenidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pirfenidone, Asbestosis