Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

NCT07820254 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Phase

Observational

Started

2026-01-10

Last updated

2026-09-15

Condition(s) studied

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Shanghai Pulmonary Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07820254 on ClinicalTrials.gov ↗ ← All trials in China