Fibrotic Interstitial Lung DiseasePhase 4NCT07141810
Efficacy and Safety of Early Antifibrotic Therapy for Non-progressive Fibrotic Interstitial Lung Disease
A Phase 4 study testing Antifibrotic drugs (nidanib or pirfenidone) in people with Fibrotic Interstitial Lung Disease, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
Early antifibrotic therapy for f-ILD Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Fibrotic Interstitial Lung Disease
- What is being tested?
- Antifibrotic drugs (nidanib or pirfenidone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 May 2028
- Phase
- Phase 4
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete this study, and sign the informed consent; 2) The age of signing the informed consent is 40-85 years old (including both ends of the value); 3) Weight: male ≥50 kg, female ≥40 kg; 4) During screening, FVC accounted for more than 45% of the estimated value and 90%; 5) The percentage of pulmonary carbon monoxide dispersion (DLCO) to the predicted value (corrected by Hb value) during screening was ≥30% and ≤90%; 6) Diagnosed with fibrotic ILD: In the past 12 months, at least 3 months after basic treatment such as glucocorticoids and immunosuppressants, reexamination of chest CT showed fibrotic features such as diffuse mesh shadow, honeycomb lung, and tractive bronchiectasis in both lungs, and the lesions could not be further absorbed.
- -
Who cannot join
- Patients with unstable disease (IPF) assessed by investigators during screening had acute exacerbations during screening or within 3 months before randomization;
- Patients who are likely to require lung transplantation within 6 months or whose expected survival is less than 1 year as assessed by the investigators at the time of screening;
- During screening, chest HRCT indicated that the range of emphysema exceeded the range of pulmonary fibrosis (based on independent imaging evaluation results);
- Patients with airway obstruction disease (such as FEV1/FVC after bronchodilator);
- Diagnosed with IPF
- Diagnosis of PPF according to the 2022 ATS/ERS/JRS/ALAT guidelines
Show all 24Show fewer
- Patients with other types of respiratory diseases that the investigators assessed might affect the study results;
- Patients who need to receive oxygen therapy for 15 hours or more per day;
- Resting pulse oxygen < 90% (sea level to 1500m above sea level) or < 85% (altitude > 1500m) when breathing indoor air during screening;
- with other poorly controlled underlying conditions (such as NYHA Class III or IV congestive heart failure, acute myocardial infarction, unstable angina, hemorrhagic or ischemic stroke, pulmonary hypertension requiring treatment within the 6 months prior to screening), Patients assessed by the investigator as unsuitable for the study;
- Patients who had an active tuberculosis infection in the 12 months prior to screening, or had a bacterial, viral, fungal, or microbial infection requiring treatment with any clinical symptoms within the 4 weeks prior to randomization;
- Patients diagnosed with NCOV infection 1 month before screening and/or during screening (NCOV nucleic acid testing is not part of this study and can be performed on demand);
- Patients who plan to receive NCOV vaccine and other vaccines from 1 month before screening to 1 month after the last dose;
- Patients with a history of malignant tumors (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within 5 years prior to screening, or who are currently being evaluated for potential malignant tumors;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 upper limit of normal (ULN) or total bilirubin ≥1.5× upper limit of normal (ULN);
- Serum creatinine ≥1.5× upper limit of normal (ULN);
- Active hepatitis, syphilis or HIV antibody positive patients;
- Major surgery (general anesthesia) within 3 months prior to screening, or surgery planned to be performed during the study period that the investigator assessed would affect the study endpoint;
- Participated in any clinical trial (including other investigational drug/investigational device therapy) within 3 months prior to screening, or was still within 5 half-lives of the investigational drug at the time of screening;
- Current smoking history, smoking cessation ≤3 months, or unable to abstain from smoking for the entire study period;
- Suspected or confirmed history of alcohol or drug abuse;
- Known allergy to the investigational drug and its ingredients;
- Pregnant and lactating women, female subjects who plan to become pregnant during the study period, or patients who do not wish to use contraceptives that meet the protocol requirements during the trial;
- Other conditions assessed by the investigator as unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Antifibrotic Therapy for f-ILD
Early antifibrotic therapy for f-ILD
- Conditions
- Fibrotic Interstitial Lung Disease
- Being tested
- Antifibrotic drugs (nidanib or pirfenidone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antifibrotic drugs (nidanib or pirfenidone)Drug
One group received primary therapy, and another group received an antifibrotic drug (nidanib or pirfenidone) in addition to primary therapy.
| Study group | Role | What they receive |
|---|---|---|
| Antifibrotic drug | Active comparator | Not described Receives: Drug: Antifibrotic drugs (nidanib or pirfenidone) |
| Primary therapy group | No intervention | One group received primary therapy，without antifibrotic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC %predict
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrotic Interstitial Lung DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group was treated with basic therapy alone, and another group was treated with basic therapy combined with antifibrotic therapy.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuwu Bai, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141810
- Sponsor's protocol ID
- 2025022295
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Antifibrotic Therapy for f-ILD
- ClinicalTrials.gov ID
- NCT07141810
- Acronym / sponsor ID
- 2025022295
- Conditions
- Fibrotic Interstitial Lung Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 26 Aug 2025 (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.
Early antifibrotic therapy for f-ILD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- One group was treated with basic therapy alone, and another group was treated with basic therapy combined with antifibrotic therapy.
| Arm | Type | Receives |
|---|---|---|
| Antifibrotic drug | Active comparator | Drug: Antifibrotic drugs (nidanib or pirfenidone) |
| Primary therapy group | No intervention | –One group received primary therapy，without antifibrotic drug |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete this study, and sign the informed consent; 2) The age of signing the informed consent is 40-85 years old (including both ends of the value); 3) Weight: male ≥50 kg, female ≥40 kg; 4) During screening, FVC accounted for more than 45% of the estimated value and 90%; 5) The percentage of pulmonary carbon monoxide dispersion (DLCO) to the predicted value (corrected by Hb value) during screening was ≥30% and ≤90%; 6) Diagnosed with fibrotic ILD: In the past 12 months, at least 3 months after basic treatment such as glucocorticoids and immunosuppressants, reexamination of chest CT showed fibrotic features such as diffuse mesh shadow, honeycomb lung, and tractive bronchiectasis in both lungs, and the lesions could not be further absorbed.
- -
Key exclusion criteria (24 listed)
- Patients with unstable disease (IPF) assessed by investigators during screening had acute exacerbations during screening or within 3 months before randomization;
- Patients who are likely to require lung transplantation within 6 months or whose expected survival is less than 1 year as assessed by the investigators at the time of screening;
- During screening, chest HRCT indicated that the range of emphysema exceeded the range of pulmonary fibrosis (based on independent imaging evaluation results);
- Patients with airway obstruction disease (such as FEV1/FVC after bronchodilator);
- Diagnosed with IPF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antifibrotic drugs (nidanib or pirfenidone)One group received primary therapy, and another group received an antifibrotic drug (nidanib or pirfenidone) in addition to primary therapy. | Drug | Antifibrotic drug |
Primary outcome
FVC %predict
Time frame: 48 weeks
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 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Fibrotic Interstitial Lung Disease
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation
Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease
Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antifibrotic drugs (nidanib or pirfenidone) in people with Fibrotic Interstitial Lung Disease, run by Shanghai Pulmonary Hospital, Shanghai, 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 24 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: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jiu-Wu Doctor (8613651602925, yv59@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC %predict (time frame: 48 weeks). 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 26 Aug 2025.