NCT07820254 Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
| NCT ID | NCT07820254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-01-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07820254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07820254 currently recruiting?
Yes, NCT07820254 is actively recruiting participants. Contact the research team at yv59@163.com for enrollment information.
Where is the NCT07820254 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07820254 clinical trial?
NCT07820254 is sponsored by Shanghai Pulmonary Hospital, Shanghai, China. The trial plans to enroll 60 participants.