A Clinical Study on Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance
研究概览
简要总结
The goal of this observational study is to learn about the inspiratory flow rate capability in patients with pulmonary fibrosis (IPF or PPF) when using inhaler devices with different resistances. The main questions it aims to answer are:
What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a medium-resistance inhaler device?
What is the peak inspiratory flow rate (PIFR) that patients with pulmonary fibrosis can achieve through a high-resistance inhaler device?
What is the inspiratory time (EIT) for each resistance level?
Participants will use a portable device called In-Check™ DIAL G16, which simulates the resistance of different dry powder inhalers. Each participant will perform two breathing tests at a medium-resistance setting and two breathing tests at a high-resistance setting, with a 2-minute rest between settings. The device measures how fast air is breathed in and how long each breath lasts.
This study will enroll 60 patients diagnosed with IPF or PPF at Shanghai Pulmonary Hospital. Participants will be involved for approximately 30 to 60 minutes, including training on how to use the device and the breathing tests. The study involves no drugs or invasive procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years (inclusive), either sex.
- •Diagnosis of pulmonary fibrosis (IPF or PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines (with traceable diagnostic evidence such as medical records, confirmed by a radiologist).
- •Forced vital capacity (FVC) ≥ 45% of predicted normal value within 2 months before screening.
- •Diffusing capacity for carbon monoxide (DLCO) > 25% of predicted normal value within 2 months before screening.
- •Voluntary participation with written informed consent.
排除标准
- •Patients with impaired consciousness, dementia, or various psychiatric disorders.
- •Patients unable to operate the inspiratory flow measurement device as instructed by the investigator.
- •Patients with major diseases or conditions other than the IPF under study that, in the investigator's judgment, may put the patient at risk by participating in the trial.
- •Any participant deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Pulmonary Fibrosis Patients
Patients aged 18-80 years with a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) according to the ATS/ERS/JRS/ALAT 2022 guidelines. Participants will perform inspiratory flow tests using the In-Check™ DIAL G16 device at both medium-resistance and high-resistance settings. No investigational drug or intervention is administered.
结局指标
主要结局
Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance
时间窗: Single visit (approximately 30-60 minutes)
Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the medium-resistance setting. Each participant will perform two breathing tests at this setting. The mean PIFR of the two valid measurements will be recorded.
Peak Inspiratory Flow Rate (PIFR) at High Device Resistance
时间窗: Single visit (approximately 30-60 minutes)
Peak inspiratory flow rate (PIFR, L/min) will be measured using the In-Check™ DIAL G16 device at the high-resistance setting. Each participant will perform two breathing tests at this setting. The mean PIFR of the two valid measurements will be recorded.
次要结局
- Inspiratory Time (EIT) at Medium and High Device Resistances(Single visit (approximately 30-60 minutes))
研究者
Jiuwu Bai
Associate Chief Physician
Shanghai Pulmonary Hospital, Shanghai, China