Idiopathic Pulmonary FibrosisNCT07820254
Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
An observational study of Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Jiuwu Bai, +86 13651602925, yv59@163.com
About this study
Official title: 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?
Read more
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.
- Keywords
- Peak Inspiratory Flow Rate, Inspiratory Flow Rate, Dry Powder Inhaler, Inhaler Device, Device Resistance
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Single visit (approximately 30-60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start10 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Jiuwu Bai, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820254
- Sponsor's protocol ID
- SHXHH-PF-DY-01
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
- ClinicalTrials.gov ID
- NCT07820254
- Acronym / sponsor ID
- SHXHH-PF-DY-01
- Keywords
- Peak Inspiratory Flow Rate, Inspiratory Flow Rate, Dry Powder Inhaler, Inhaler Device, Device Resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Inspiratory Time (EIT) at Medium and High Device Resistances
Time frame: Single visit (approximately 30-60 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiuwu Bai (+86 13651602925, yv59@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Inspiratory Flow Rate (PIFR) at Medium Device Resistance (time frame: Single visit (approximately 30-60 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.