Stable idiopathic pulmonary fibrosis
Conditions
Interventions
Observation group:None
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged 40 years or older. 2) The study participant has signed the informed consent form, understands the purpose, procedures, and content of the study, and voluntarily agrees to participate. 3) Diagnosed with IPF according to the ATS/ERS/JRS/ALAT Clinical Practice Guideline for Idiopathic Pulmonary Fibrosis (2022), with HRCT showing a UIP pattern or probable UIP pattern (confirmed by an independent imaging review panel), with or without a pathological UIP pattern or probable UIP pattern; or HRCT showing an indeterminate UIP pattern, with pathology confirming a UIP pattern or probable UIP pattern (pathology refers to transbronchial cryobiopsy or surgical/thoracoscopic lung biopsy). 4) Study participants receiving background antifibrotic therapy with pirfenidone or nintedanib may be enrolled if they have been on a stable antifibrotic regimen for more than 12 weeks prior to Visit 1. 5) IPF patients with at least two pulmonary function test results within the previous 2 years. 6) Adequate organ function, with laboratory results for complete blood count, liver and kidney function, and coagulation performed within 7 days prior to starting treatment meeting the following criteria: white blood cell (WBC) count >= 3.5×10^9/L, platelet (PLT) count >=80×10^9/L, absolute neutrophil count (ANC) >= 1.5×10^9/L, hemoglobin (HGB) >= 90 g/L, aspartate aminotransferase (AST) < 2.5× upper limit of normal (ULN) (< 5×ULN in patients with liver metastases), alanine aminotransferase (ALT) < 2.5×ULN (< 5×ULN in patients with liver metastases), total bilirubin (TIBC) < 1.5×ULN, serum creatinine (CR) < 1.0×ULN, and prothrombin time, partial thromboplastin time, plasma fibrinogen, and thrombin time within normal range.
Exclusion criteria
Exclusion criteria: 1) Patients with acute exacerbation of IPF within 4 weeks prior to screening or during the screening period. 2) Presence of interstitial lung disease (ILD) other than IPF, including but not limited to: any other type of idiopathic interstitial pneumonia; lung disease associated with fibrogenic agents, other environmental toxins, or drugs; other types of occupational lung disease; granulomatous lung disease; pulmonary vascular disease; systemic diseases including vasculitis, infectious diseases (e.g., tuberculosis), and connective tissue diseases. If the diagnosis is unclear, serological testing and/or multidisciplinary expert panel review should be performed to confirm IPF or other types of ILD. 3) Active viral, bacterial, or fungal infection that is not controlled with appropriate anti-infective therapy. 4) History of malignancy (except for cancers that have been cured or in remission for >=5 years, radically resected basal cell or squamous cell skin cancer, in situ cervical cancer, and resected colonic polyps). 5) Known positive serology for HIV or syphilis, or active hepatitis B virus or hepatitis C virus infection. 6) Presence of mental illness or other conditions that preclude compliance with study treatment and monitoring requirements. 7) Known allergy to any component of the immunomodulatory agent. 8) Organ transplant recipients. 9) Judged by the investigator to be unable to complete study follow-up. 10) Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom Assessment ;Vital Signs and Physical Examination;Pulmonary Function Tests;Exercise Tolerance Assessment;High-Resolution Chest CT Scan;Lung Surgical Biopsy Pathology Assessment;Laboratory Tests; | — |
Countries
China
Contacts
Public ContactTing Yang; Xiawei Wei
West China Hospital, Sichuan University
Outcome results
None listed