Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07820254

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Progressive Pulmonary Fibrosis Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Jiuwu Bai

CONTACT

[email protected]

+86 13651602925

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance

    Time frame: 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.

  2. Peak Inspiratory Flow Rate (PIFR) at High Device Resistance

    Time frame: 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.

Secondary outcomes

  1. Inspiratory Time (EIT) at Medium and High Device Resistances

    Time frame: Single visit (approximately 30-60 minutes)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiuwu Bai

CONTACT

[email protected]

+86 13651602925

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Collaborators

  • Shanghai Xin Huanghe Pharmaceutical Co., Ltd.

Registry information

Official study title

A Clinical Study on Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.