Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- radiological findings change
研究概览
简要总结
This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Pirfinedone group
asbestosis patients given pirfenidone drug
干预措施: Pirfenidone (Drug)
结局指标
主要结局
radiological findings change
时间窗: after 6 months and 12 months from the start of the trial
radiological changes in High resolution computed topography.
Ventilatory function change
时间窗: after 6 months and 12 months from the start of the trial
Absolute change in percent predicted forced vital capacity
Diffusion test
时间窗: after 6 months and 12 months from the start of the trial
Diffusion test change from baseline
次要结局
未报告次要终点
研究者
Marwa Mohammed Fouad
Lecturer of Occupational and environmental Medicine
Cairo University