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Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

Recruitingn/aAges 18 Years - 80 YearsAllShanghai Pulmonary Hospital, Shanghai, China
NCT07820254 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 m

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Shanghai Pulmonary Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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