fibrosing interstitial lung disease
Conditions
Interventions
Treatment group:Treatment period: standard treatment (decided by clinical investigator) + butaselen tablet (450mg)
Day1-Day6(D1-D6), orally, b.i.d
Day7(D7), qd
Extension period: standard treatment (decided by clinical investigator) + butaselen tablet (450mg)
Day11-D84 orally, b.i.d
Treatment group:Treatment period: standard treatment (decided by clinical investigator) + butaselen tablet (600mg)
Extension period: standard treatment (decided by clinical investigator) + butaselen tablet (600mg)
Placebo group:Treatment period: standard treatment (decided by clinical investigator) + placebo
Extension period: standard treatment (decided by clinical investigator) + placebo
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.both sexes, aged 18-70 years (inclusive), and written informed consent provided; 2.disease and conditions: (1)diagnosed of fibrotic interstitial lung diseases (F-ILDs) (predominantly non-specific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (CHP), unclassifiable idiopathic interstitial pneumonia (U-IIP), and interstitial pneumonitis with autoimmune features (IPAF)] for =2 months; and with findings of a) and/or b) as follows: a)with fibrosing lung disease affecting greater than 10% lung volume on HRCT, the radiographic features including the widening of interlobular septa, reticular abnormality, traction bronchiectasis/bronchiolectasis, destruction of lung structure, honeycombing with or without ground-glass opacity; b)histological findings fibrosing through lung biopsy[transbronchial lung biopsy (TBLB) / transbronchial lung cryobiopsy (TBLC) / video-assisted thoracoscopic (VATS)] including widening of alveolar septa or interlobular septa, proliferation of fibroblast cells, deposition of collagens, traction bronchiolectasis, honeycombing and structural destruction; (2)The forced vital capacity (FVC) >=45% of predicted and DLco >=35% of predicted value in screening and at baseline; 3.The participants (including male) do not plan of pregnancy, also who will use effective contraception voluntarily, and do not donate sperm or eggs during the entire period of screening and the trial (details in Appendix 2); 4.The participants understand the procedures and details of this trial and take part in the trial voluntarily with written informed consent; the participants will comply completely with the indications in the trial.
Exclusion criteria
Exclusion criteria: 1.Allergics, or known allergic history to ingredients in investigational product, and who are not appropriate for the trial as judged by clinical investigator. 2.Diagnosed of connective tissue disease-related interstitial lung disease(CTD-ILD), vasculitis-related interstitial lung disease, idiopathic pulmonary fibrosis (IPF). 3.Arterial partial pressure of oxygen (PaO2) =1 month; nintedanib 100-150 mg, b.i.d, for >=1 month); or antioxidant therapy (acetylcysteine 0.6 g, t.i.d, for >=1 month) within 1 month prior to screening. 8.Started standard immunosuppressive therapy (excluding glucocorticoids) including, but not limited to, cyclophosphamide, azathioprine, methotrexate, cyclosporine, tacrolimus, merti-macrolide, and tolizumab within 1 month prior to screening; rituximab within 6 months. 9.Have received (pathogenecity attenuated) live vaccine within 12 weeks prior to the first dose or plan to receive any (pathogenecity attenuated) live vaccine during the study period (except those who have received SARS-CoV-2 vaccine or vaccine booster for =4 weeks). 10.The participant will be excluded with any disease condition or history as in followings: (1).the participant is unable to take the drug orally or has noticeable gastrointestinal absorption deficits; (2).have severe pulmonary hypertension (peak tricuspid regurgitation flow rate > 3.4 m/s on cardiac ultrasound), or extrapulmonary pathological abnormalities (e.g., chest wall deformities, large volume pleural effusions); (3).myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty(PTCA), coronary artery bypass grafting, heart failure (New York Heart Association Cardiac Function Class >II), transient ischemic attack (TIA), cerebral vascular infarction, cerebral hemorrhage, or subarachnoid hemorrhage in the 3 months prior to screening; (4).comorbidities such as the unstable cardiovascular disease (e.g., blood pressure failed to be controlled after 3 months of standard treatment for hypertension, systolic blood pressure(SBP) >=160 mmHg and/or diastolic blood pressure(DBP) >=100 mmHg); (5).participant with history of malignancy (except those who have achieved complete remission for five years prior to the screening of this study, who do not require any other treatment currently or during the following study period); (6).diagnosed cardiovascular, hepatic, renal, gastrointestinal, immune, endocrine, metabolic, psychiatric and/or psychological, neurological, and hematological and lymphatic systems prior to screening period, and not appropriate for the trial as judged by the clinical investigator; 11.The participant will be excluded with any abnormality of laboratory test of imaging as in followings: (1).blood cell count: hemoglobulin1.5 times of upper limits of normal (ULN); (3).renal function: creatinine clearance =1.5 times of the upper limit of normal [measured values, or values c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events;serious adverse events;adverse drug reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactDai Huaping
China-Japan Friendship Hospital
Outcome results
None listed