A Randomized Crossover Trial of Indoor Air Quality Improvement on Health in Patients With Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Pulmonary Function Indicators (e.g., Pulmonary Diffusing Capacity)
研究概览
简要总结
Air pollution threatens the respiratory health of patients with interstitial lung disease (ILD). High-efficiency air purifiers, featuring easy operation and excellent particulate matter removal efficiency, have been shown in previous studies to potentially delay lung function deterioration and reduce acute exacerbation risk in respiratory disease patients. This randomized crossover study employs air purifiers to filter indoor gaseous pollutants, allergens, and other contaminants, aiming to alleviate respiratory irritation, improve daily life comfort, and enhance overall health status in ILD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with interstitial lung disease (ILD).
- •Stable disease status, defined as no hospitalization due to acute exacerbation within the past month.
排除标准
- •Patients with complications of severe organ failure (including heart, liver, or kidney failure), malignant tumors, or mental disorders.
- •A history of respiratory tract infection within the past two weeks.
结局指标
主要结局
Pulmonary Function Indicators (e.g., Pulmonary Diffusing Capacity)
时间窗: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
Symptom Improvement-related Indicators (e.g., Improvement in Respiratory Symptom Score)
时间窗: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
St. George's Respiratory Questionnaire (SGRQ):Score Range:Minimum score: 0 points;Maximum score: 100 points.A higher score indicates worse outcomes for the patient.
Quality of Life Indicators (e.g., CAT Score)
时间窗: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
COPD Assessment Test (CAT):It is a short, validated, patient-reported outcome (PRO) tool specifically designed to measure the impact of pulmonary disease on a patient's health status and daily life.Score Range:Minimum score: 0 points;Maximum score: 40 points.A higher score indicates worse health status and greater pulmonary disease-related burden for the patient.
Blood Sample Indicators (e.g., Concentration of Interleukin-8)
时间窗: Baseline (before intervention), Week 2 (end of first phase), Week 6 (end of second phase)
Assessment of Changes in Pulmonary Inflammation or Lung Injury Before and After Intervention Using Concentrations of Biomarkers Such as Interleukin-8
次要结局
未报告次要终点
研究者
Hongbing Xu
Prof.
Peking Union Medical College