Efficacy and Safety of Early Antifibrotic Therapy for Non-progressive Fibrotic Interstitial Lung Disease

NCT07141810 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025022295
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

Early antifibrotic therapy for f-ILD

Conditions

Fibrotic Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• FVC %predict

  48 weeks

Study Arms (2)

Antifibrotic drug

ACTIVE COMPARATOR

Drug: Antifibrotic drugs (nidanib or pirfenidone)

Primary therapy group

NO INTERVENTION

One group received primary therapy，without antifibrotic drug

Interventions

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.

Antifibrotic drug

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• 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
• 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);

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Interventions

pirfenidone

Central Study Contacts

Jiu-Wu Doctor

CONTACT

8613651602925; yv59@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: One group was treated with basic therapy alone, and another group was treated with basic therapy combined with antifibrotic therapy.

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: August 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08