Asbestosis
Conditions
Keywords
Pirfenidone, Asbestosis
Brief summary
This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.
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.
Interventions
DRUGPirfenidone
drug intake three times daily for one year
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diffusion test | after 6 months and 12 months from the start of the trial | Diffusion test change from baseline |
| Ventilatory function change | after 6 months and 12 months from the start of the trial | Absolute change in percent predicted forced vital capacity |
| radiological findings change | after 6 months and 12 months from the start of the trial | radiological changes in High resolution computed topography. |
Contacts
Primary ContactMarwa M Fouad, MD
Backup ContactMohammed Elbatanouny, MD
Outcome results
None listed