Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
A Clinical Study on Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jiuwu Bai
- Phone Number: +86 13651602925
- Email: yv59@163.com
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital
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Contact:
- Jiuwu Bai
- Phone Number: +86 13651602925
- Email: yv59@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance
Time Frame: Single visit (approximately 30-60 minutes)
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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.
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Single visit (approximately 30-60 minutes)
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Peak Inspiratory Flow Rate (PIFR) at High Device Resistance
Time Frame: Single visit (approximately 30-60 minutes)
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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.
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Single visit (approximately 30-60 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Inspiratory Time (EIT) at Medium and High Device Resistances
Time Frame: Single visit (approximately 30-60 minutes)
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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.
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Single visit (approximately 30-60 minutes)
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHXHH-PF-DY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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