Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

NCT07820254 | Recruiting

• 1 other identifier: SHXHH-PF-DY-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis

Keywords

Peak Inspiratory Flow Rate; Inspiratory Flow Rate; Dry Powder Inhaler; Inhaler Device; Device Resistance

Outcome Measures

Primary Outcomes (2)

• 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.

  Single visit (approximately 30-60 minutes)

• 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.

  Single visit (approximately 30-60 minutes)

Secondary Outcomes (1)

• Inspiratory Time (EIT) at Medium and High Device Resistances

  Single visit (approximately 30-60 minutes)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Shanghai Xin Huanghe Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jiuwu Bai

CONTACT

+86 13651602925; yv59@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

CN (1)