Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Forced Vital Capacity (FVC)
研究概览
简要总结
This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis. This study included 40 adult patients (≥ 18 years) with a diagnosis of chronic progressive hypersensitivity pneumonitis. The included patients were divided into 2 groups 20 patients in each one.
Group 1: will receive pirfenidone in addition to the conventional treatment Group 2: will be maintained on conventional treatment. Forced vital capacity (FVC),6 minutes walking test(6MWT), oxygen tension in the arterial blood (PaO2), and St. George's Respiratory Questionnaire (SGRQ ) were measured before and after 6 months of a pirfenidone treatment trial.
Results
详细描述
Rationale The present data about the treatment of CHP are few and largely based on observational studies and expert opinion. It is suggested that pirfenidone may slow disease progression in cases of CHP as it has some anti-inflammatory in addition to antifibrotic effects.
Hypothesis Pirfenidone will slow disease progression in hypersensitivity pneumonitis patients
Research questions
- Can pirfenidone slow disease progression in cases of CHP?
- What about the safety of pirfenidone in cases of CHP?
This study aims to evaluate the efficacy of pirfenidone in chronic hypersensitivity pneumonitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old with a diagnosis of chronic progressive Hypersensitivity pneumonitis:
- •>10% extent of fibrosis (eg, reticulation) on high-resolution CT (HRCT) scan
- •Absolute decline in FVC% predicted >5% within the previous 6 months despite conventional treatment.
排除标准
- •Pregnancy or breastfeeding period
- •Patients with peptic ulcer, severe hepatic disease, severe kidney disease, severe cardiac disease, and patients with other chronic pulmonary diseases.
- •Presence of active infection
- •History of alcohol or drugs abuse
- •Active smokers
研究组 & 干预措施
Oral pirfenidone
Pirfenidone will be administered orally in 267 mg capsules taken with food. The dose will be titrated over 2 weeks from one capsule three times a day during Week 1 to two capsules three times a day during Week 2 then maintenance dose (three capsules three times a day Week 3.
干预措施: Oral pirfenidone (Drug)
Standard care
Standard care
干预措施: Standard care (Drug)
结局指标
主要结局
Forced Vital Capacity (FVC)
时间窗: Baseline to 6 months
Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration,. FVC is the most basic maneuver in spirometry tests.
6 minutes walking distance
时间窗: Baseline to 6 months
The 6-min walk test (6MWT) has gained importance in the assessment of functional exercise capacity in patients with chronic respiratory disease.
次要结局
未报告次要终点
研究者
Eman Shebl
Assistant professor
Zagazig University