Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
A total of 60 patients with pulmonary fibrosis (IPF or PPF) diagnosed according to the ATS/ERS/JRS/ALAT 2022 guidelines will be enrolled at Shanghai Pulmonary Hospital. Eligible participants are aged 18-80 years, either sex, with FVC ≥ 45% of predicted and DLCO \> 25% of predicted within 2 months before screening. All participants will perform inspiratory flow tests at medium and high device resistances.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Pulmonary Fibrosis Patients
Trial outcomes
Primary outcomes
1
Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance
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.
Time frame
Single visit (approximately 30-60 minutes)2
Peak Inspiratory Flow Rate (PIFR) at High Device Resistance
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.
Time frame
Single visit (approximately 30-60 minutes)Secondary outcomes
1
Inspiratory Time (EIT) at Medium and High Device Resistances
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.
Time frame
Single visit (approximately 30-60 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov