IPF&PF-ILD
Conditions
Interventions
placebo :Aerosol inhalation for 7 consecutive days, physiological saline, 2g/ bottle.
low dose group:Aerosol inhalation for 7 consecutive days, low dose LSC-SEC, 2g/ bottle.
high dose group:Aerosol inhalation for 7 consecutive days, low dose LSC-SEC, 2g/ bottle.
Sponsors
Shiyan Taihe Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men or women between the ages of 40 and 75 years (including both extremes). 2. Diagnosed with IPF or diagnosed with PPF within 5 years prior to the screening visit, according to the guidelines for the diagnosis of idiopathic pulmonary fibrosis published jointly by the American Thoracic Society (ATS), the European Respiratory Societies (ERs), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Society (ALAT). 3. HRCT review results within 12 months that meet the requirements for the diagnosis of IPF (Diagnostic Guidelines for Idiopathic Pulmonary Fibrosis published jointly by the American Thoracic Society (ATS), the European Respiratory Societies (ERs), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Society (ALAT)). 4. Exertion spirometry (FVC) greater than 40% of the predicted value and the ratio of exertion expiratory volume in 1 second to FVC (FEV1/FVC) greater than 0.75 (pulmonary function tests must be completed no more than 90 days prior to screening). 5. Diffusing carbon monoxide (DLCO) capacity greater than 25% of predicted volume. 6. Blood partial pressure of oxygen (PaO2) greater than or equal to 55 mmHg (sea level to 1500 meters) or 50 mmHg (above 1500 meters) room atmosphere. 7. Ability to perform a 6-minute walk test (6MWT) at screening. 8. Be able to understand the information provided in the Human Research and Ethics Committee (HREC) approved ICF and must sign the form before starting any study procedures.
Exclusion criteria
Exclusion criteria: 1. Active or recent (less than 60 days prior to enrollment) significant respiratory infection or a history of frequent (more than 2 per year for the past 2 years) infectious exacerbations of IPF. 2. Chronic heart failure (NYHA class III/IV) or known left ventricular ejection fraction less than 45%. 3. Acute or chronic injury (other than dyspnea) that limits the ability to comply with study requirements and procedures (including 6MWT). 4. Subject requires hemodialysis, peritoneal dialysis or hemofiltration. 5. Systolic blood pressure is less than 85 mmHg. 6. History of malignancy within the past 5 years, except squamous or basal cell carcinoma of the skin or successful treatment of carcinoma in situ of the cervix. 7. Pregnant or lactating females. Female subjects of childbearing age will have a blood or urine pregnancy test at screening. 8. Patients who have received an organ transplant and patients who have received a lung transplant less than one year ago. 9. Known history of severe alcohol abuse within 1 year. 10. Participation in a clinical study involving another investigational drug or device within 90 days prior to screening. 11. Expected survival of <1 year in the judgment of the investigator. 12. Severe medical or psychiatric illness that, in the investigator's assessment, would interfere with treatment. 13. Patients with HIV infection. 14. Patients with active hepatitis. 15. Patients with moderate to severe hepatic insufficiency: total bilirubin greater than or equal to 1*ULN, aminotransferases (AST and ALT) greater than or equal to 1.5*ULN and alkaline phosphatase (ALP) greater than or equal to 1*ULN. 16. Absolute neutrophil count less than 1.5*10^9/L. 17. Moderate to severe renal insufficiency: serum creatinine greater than or equal to 1.5*ULN and serum creatinine clearance less than or equal to 50ml/min. 18. Patients using oral glucocorticoids, nidaneb or pirfenidone within 60 days of acute exacerbation of IPF/PF-ILD, excluding patients using nidaneb or pirfenidone in the stabilized phase and patients with stable CTD-ILD progression who are maintained on no more than 10mg of prednisone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Vital Capacity, FVC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diffusing Capacity of the Lung for Carbon Monoxide, DLCO;Six Minute Walk Test, 6MWT;quantitative lung fibrosis score, QLF score ; | — |
Countries
China
Contacts
Public ContactTang Yijun
Shiyan Taihe Hospital
Outcome results
None listed