Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Conditions
Keywords
Peak Inspiratory Flow Rate, Inspiratory Flow Rate, Dry Powder Inhaler, Inhaler Device, Device Resistance
Brief summary
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.
Interventions
None listed
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years (inclusive), either sex. 2. 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). 3. Forced vital capacity (FVC) ≥ 45% of predicted normal value within 2 months before screening. 4. Diffusing capacity for carbon monoxide (DLCO) \> 25% of predicted normal value within 2 months before screening. 5. Voluntary participation with written informed consent.
Exclusion criteria
1. Patients with impaired consciousness, dementia, or various psychiatric disorders. 2. Patients unable to operate the inspiratory flow measurement device as instructed by the investigator. 3. 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. 4. Any participant deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Time (EIT) at Medium and High Device Resistances | Single visit (approximately 30-60 minutes) | Inspiratory time (EIT, seconds) will be measured using the In-Check™ DIAL G16 device at two resistance settings: medium resistance and high resistance. Each participant will perform two breathing tests at each resistance setting. The mean EIT of the two valid measurements at each resistance level will be recorded and compared between the two settings. |
Countries
China
Contacts
CONTACTJiuwu Bai
Outcome results
None listed