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临床试验/NCT06650774
NCT06650774已完成不适用

Comparison of the Effects of Nintedanib and Pirfenidone on Pulmonary Function Test Parameters and Radiological Findingsin Patients With Pulmonary Fibrosis

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2024年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
1
主要终点
Comparison of pulmonary function test parameters of pirfenidone and nintedanip groups after 1-year follow-up

研究概览

简要总结

The goal of this observational study is to compare the effects of pirfenidone and nintedanib on lung function and radiologic findings in fibrotic lung diseases. The main question it aims to answer is:

• Do these two drugs have equivalent effects on progression in patients with pulmonary fibrosis? If there is a comparison group: The investigators will compare patients with pulmonary fibrosis receiving pirfenidone with patients with pulmonary fibrosis receiving nintedanip.

The investigators will compare patients with pulmonary fibrosis receiving pirfenidone and patients with pulmonary fibrosis receiving nintedanip.

Pulmonary function test parameters at 3rd, 6th, 9th and 12th months and differences of 6 MWT parameters compared to baseline will be compared between the two groups.

详细描述

The data of patients who were started Pirfenidone or Nintedanib treatment with the diagnosis of Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis according to An Official ATS/ERS/JRS/ALAT Clinical Practice guideline and treated for at least one year in our department between January 1, 2010 and December 31, 2022 were retrospectively analyzed. The included patients had not previously used steroids or similar drugs for lung disease. The study was initiated after approval of the local ethics committee.

File information, pulmonary function test parameters and radiologic data, gender, age and comorbidity information of all patients were obtained from the hospital database. Pulmonary function tests were performed using a COSMED Quark 2021 model device. Patients were divided into two groups as nintedanib and pirfenidone group and both groups were compared in terms of progression in pulmonary function tests and radiologic findings within 1 year of diagnosis. For this purpose, the difference of pulmonary function test parameters (FVC (mL-%), FEV1 (mL-%), FEV1/FVC, FEF25-75 (mL-%), and 6-minute walk test values at the 3rd, 6th, 9th and 12th months of all patients from the baseline values at the time of diagnosis were analyzed and these differences were compared between the two groups.Thorax CT findings were also compared between the two groups for the presence of progression. Patients whose radiologic and PFT data at initial presentation were not available, patients whose treatment was discontinued before 1 year due to side effects or unresponsiveness or death, and patients who were switched between the two drugs before 1 year had elapsed were excluded from the study.

Statistical analysis Kolmogorov-Smirnov test was used to test the normal distribution of the continuous variables. The data characterized by a normal distribution are expressed as mean±standard deviation. Student's t-tests was used for the comparison of the data which had a normal distribution. Mann-Whitney-U test was used for the comparison of the non-normally distributed data. The discrete variables were compared using Chi-squared test. P <0.05 was considered to be statistically significant. The data were analyzed using the SPSS statistical software (version 13.01, serial number 9069728, SPSS Inc., Chicago).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients who were started Pirfenidone or Nintedanib treatment with the diagnosis of Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis according to An Official ATS/ERS/JRS/ALAT Clinical Practice guideline and treated for at least one year in our department between January 1 2010 and December 31 2022 The included patients had not previously used steroids or similar drugs for lung disease.
  • Patients aged 18 years who have not used steroids or similar medication after diagnosis

排除标准

  • Patients whose radiologic and PFT data at initial presentation were not available -Patients whose treatment was discontinued before 1 year due to side effects or unresponsiveness or death
  • Patients who were switched between the two drugs before 1 year had elapsed

结局指标

主要结局

Comparison of pulmonary function test parameters of pirfenidone and nintedanip groups after 1-year follow-up

时间窗: January 1 2010 and December 31 2022

SFT values at 3, 6, 9 and 12 months were compared with baseline values and the difference between the two groups was analyzed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olcay Ayçiçek

Asist Proof

Karadeniz Technical University

研究点 (1)

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