JPRN-UMIN000015508已完成未知
A prospective randomized, multicenter trial evaluating the efficacy and safety of combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis. - Combined therapy with pirfenidone and inhaled N-acetylcysteine for idiopathic pulmonary fibrosis.
Grant for Research on Diffuse Lung Disease from the Ministry of Health, Labour and Welfare of Japan.0 个研究点目标入组 81 人开始时间: 2014年10月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 81
研究概览
简要总结
There was no difference between the two groups in the of change in FVC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1.coexisting severe cardiovascular disease 2.coexisting severe liver disfunction 3.coexisting chronic kidney disease 4.patients who had a history of receiving chemotherapy or thoracic radiotherapy 5.patients who are pregnant or possibly pregnant, or nursing 6.patients who were unable to undergo physiologic tests 7.candidates for lung transplantation 8.improving physiologic tests or HRCT findings compared with previous 6 months. 9.patient who were administered with 20 mg/day or more of predonisolone during the preceding 3 months. Treated with NAC or nintedanib during the preceding 3 months. 10.treated with immunosuppressive agents. 11.coexisting pulmonary arterial hypertension, bronchial asthma,sarcoidosis,bronchiectasis, neoplasm,infectious disease. 12.patients who participated in another clinical study within 3 months prior to the administration period of the study drug. 13.considered ineligible for the study by the investigator.
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