Progressive Pulmonary FibrosisNCT07683728
A Prospective, Multi-Center Registry Study of Progressive Pulmonary Fibrosis (PPF) in China (PROFINA)
An observational study of Progressive Pulmonary Fibrosis, run by Zuojun Xu at 1 site in China.
Trial summary
This is a nationwide multicenter prospective non-interventional registry study enrolling 600 Chinese patients diagnosed with PPF over a 3-year period (9-month enrollment, 2-year follow-up, and 3 months for data analysis and publication). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Progressive Pulmonary Fibrosis
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to 31 Oct 2029
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with PPF in China
Who may be able to join
- Diagnosis of PPF within the past year, according to the 2022 ATS/ERS/JRS/ALAT guidelines;
- Patients who are willing to participate in the study and have signed an informed consent form.
Who cannot join
- Patients diagnosed with IPF.
- Patients without baseline chest HRCT.
- Patients who refuse to sign the informed consent form.
- Patients participating in other clinical trials for medications. (Patients who have completed other trials or are in an unblinded phase after a washout period of 2 weeks are eligible for enrollment.)
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
Peking Union Medical College Hospital
Beijing
Zuojun Xu, +86 13671345136, xuzi@hotmail.com
About this study
This is a nationwide multicenter prospective non-interventional registry study enrolling 600 Chinese patients diagnosed with PPF over a 3-year period (9-month enrollment, 2-year follow-up, and 3 months for data analysis and publication). Eligible participants must meet the PPF criteria defined by the 2022 ATS/ERS/JRS/ALAT guidelines, while patients with IPF, no baseline chest HRCT, or refusal to sign informed consent will be excluded. The primary endpoint is the absolute change in FVC (mL) at 1- and 2-year follow-ups. The core objective is to investigate real-world disease progression in Chinese PPF patients, with secondary objectives to analyze their clinical characteristics, current treatment status, and unmet clinical needs.
- Conditions
- Progressive Pulmonary Fibrosis
- Keywords
- Progressive Pulmonary Fibrosis, Registry Study
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 |
|---|---|---|
| Chinese PPF Prospective Registry Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in FVC (mL)
Absolute change in FVC (mL) at 1-year and 2-year follow-up.
Measured: at 1-year and 2-year follow-up
Secondary outcomes (10)
CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs
The percentage of patients with CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs at baseline and following 2 years of follow-up.
Measured: at baseline and after 2 years of follow-up
The percentage of patients who meet at least two of the following three inclusion criteria for PPF
The percentage of patients who meet at least two of the following three inclusion criteria for PPF at baseline, 1-year, and 2-year follow-up:
- Worsening respiratory symptoms;
- Physiological evidence of disease progression (FVC decline >5% or DLCO
- Imaging evidence of disease progression (e.g., increased or worsened traction bronchiectasis, new ground-glass opacities with traction bronchiectasis, new reticular patterns, or new honeycombing).
Measured: at baseline, 1-year, and 2-year follow-up
The percentage of patients receiving treatment with corticosteroids, immunosuppressive agents, and antifibrotic drugs or PDE4B inhibitors
The percentage of patients receiving treatment with corticosteroids, immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, azathioprine, and other commonly used immunosuppressants for ILDs), and antifibrotic drugs (nintedanib, pirfenidone) or PDE4B inhibitors (e.g., nerandomilast) during the 2-year follow-up period.
Measured: during the 2-year follow-up period
Change in absolute DLCO of pulmonary function expressed as percent predicted
Change in absolute DLCO of pulmonary function expressed as percent predicted after 1 year and 2 years of follow-up.
Measured: after 1 year and 2 years of follow-up
Changes in the absolute score of the dyspnea severity questionnaire
Changes in the absolute score of the dyspnea severity questionnaire at 1-year and 2-year follow-up.
Measured: at 1-year and 2-year follow-up
Changes in the absolute score of the Cough Severity Numerical Rating Scale (CNSRS)
Changes in the absolute score of the Cough Severity Numerical Rating Scale (CNSRS) at 1-year and 2-year follow-up.
Measured: at 1-year and 2-year follow-up
Frequency of acute exacerbations of ILD
Frequency of acute exacerbations of ILD during the 2-year follow-up.
Measured: during the 2-year follow-up
Time to first acute exacerbation
Time to first acute exacerbation during the 2-year follow-up.
Measured: during the 2-year follow-up
The percentage of patients with acute exacerbations, lung transplantation, or death
The percentage of patients with acute exacerbations, lung transplantation, or death at 2-year follow-up.
Measured: at 2-year follow-up
The percentage of patients with ILD progression (FVC decline >10% of predicted value)
The percentage of patients with ILD progression (FVC decline >10% of predicted value) at 2-year follow-up
Measured: at 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start23 Sep 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Pulmonary FibrosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zuojun Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor-investigator, Zuojun Xu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683728
- Sponsor's protocol ID
- PROFINA
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Jul 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Registry Study of Progressive Pulmonary Fibrosis (PPF) in China (PROFINA)
- ClinicalTrials.gov ID
- NCT07683728
- Acronym / sponsor ID
- PROFINA
- Conditions
- Progressive Pulmonary Fibrosis
- Keywords
- Progressive Pulmonary Fibrosis, Registry Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Zuojun XuUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 6 Jul 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.
This is a nationwide multicenter prospective non-interventional registry study enrolling 600 Chinese patients diagnosed with PPF over a 3-year period (9-month enrollment, 2-year follow-up, and 3 months for data analysis and publication). Eligible participants must meet the PPF criteria defined by the 2022 ATS/ERS/JRS/ALAT guidelines, while patients with IPF, no baseline chest HRCT, or refusal to sign informed consent will be excluded. The primary endpoint is the absolute change in FVC (mL) at 1- and 2-year follow-ups. The core objective is to investigate real-world disease progression in Chinese PPF patients, with secondary objectives to analyze their clinical characteristics, current treatment status, and unmet clinical needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese PPF Prospective Registry Cohort | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with PPF in China
Key inclusion criteria (2 listed)
- Diagnosis of PPF within the past year, according to the 2022 ATS/ERS/JRS/ALAT guidelines;
- Patients who are willing to participate in the study and have signed an informed consent form.
Key exclusion criteria (4 listed)
- Patients diagnosed with IPF.
- Patients without baseline chest HRCT.
- Patients who refuse to sign the informed consent form.
- Patients participating in other clinical trials for medications. (Patients who have completed other trials or are in an unblinded phase after a washout period of 2 weeks are eligible for enrollment.)
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
Absolute change in FVC (mL)
Time frame: at 1-year and 2-year follow-up
Absolute change in FVC (mL) at 1-year and 2-year follow-up.
10 secondary outcomes
CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs
Time frame: at baseline and after 2 years of follow-up
The percentage of patients who meet at least two of the following three inclusion criteria for PPF
Time frame: at baseline, 1-year, and 2-year follow-up
The percentage of patients receiving treatment with corticosteroids, immunosuppressive agents, and antifibrotic drugs or PDE4B inhibitors
Time frame: during the 2-year follow-up period
Change in absolute DLCO of pulmonary function expressed as percent predicted
Time frame: after 1 year and 2 years of follow-up
Changes in the absolute score of the dyspnea severity questionnaire
Time frame: at 1-year and 2-year follow-up
Changes in the absolute score of the Cough Severity Numerical Rating Scale (CNSRS)
Time frame: at 1-year and 2-year follow-up
Frequency of acute exacerbations of ILD
Time frame: during the 2-year follow-up
Time to first acute exacerbation
Time frame: during the 2-year follow-up
The percentage of patients with acute exacerbations, lung transplantation, or death
Time frame: at 2-year follow-up
The percentage of patients with ILD progression (FVC decline >10% of predicted value)
Time frame: at 2-year follow-up
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 6 Jul 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 Progressive Pulmonary Fibrosis, run by Zuojun Xu 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 2 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 6 Jul 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 Zuojun Xu Zuojun Xu (+86 13671345136, xuzi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in FVC (mL) (time frame: at 1-year and 2-year follow-up). 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 6 Jul 2026.