silicosis
Conditions
Interventions
high-dose group:tiloronoxim hydrochloride tablets
low-dose group:tiloronoxim hydrochloride tablets
placebo group:placebo
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patients who fullfilled all of the following inclusion criteria will be involved in the study. (1) 18 to 75 years of age at randomization; (2) a diagnosis of simple silicosis by silica exposure history and chest image based on the 2011 International Labour Office (ILO) classification; (3) percent forced vital capacity (%FVC) =40% at screening; (4) percent diffusing capacity of the lung for carbon monoxide (%DLCO) =30% at screening; (5) PaO2 =55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air at screening.
Exclusion criteria
Exclusion criteria: The patients who fullfilled any of the following exclusion criteria will not be involved in the study. The patients (1) have continuous silica dust exposure; (2) have a history of significant exposure to organic dust other than silica known to cause pneumoconiosis; (3) have interstitial lung disease other than silicosis; (4) have pulmonary fibrosis associated with connective tissue disease; (5) have uncontrolled asthma; (6) have active infection; (7) have progressive massive fibrosis (PMF) of the silicosis; (8) are listed for lung transplantation at the time of study enrollment; (9) have AST, ALT > 1.5 x ULN; (10) have Bilirubin > 1.5 x ULN; (11) have significant eye diseases; (12) have significant heart problems; (13) have uncontrolled systemic arterial hypertension; (14) have Haemoglobin < 9.0 g/dL; (15) have other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial; (16) have suffered from malignancy; (17) are pregnant or lactating (if female); (18) are participating in other clinical trials or have participated in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of FVC predicted% compared with baseline at 48 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of FEV1 predicted% compared with baseline at 48 weeks;Change of TLC predicted% compared with baseline at 48 weeks;Change of DLCO SB predicted% compared with baseline at 48 weeks;Change of 6 MWD compared with baseline at 48 weeks;Change of St Georges questionnaire compared with baseline at 48 weeks;Change of dyspnea compared with baseline at 48 weeks;Changes of chest X-ray and CT evaluations compared with baseline at 48 weeks;Changes of KL-6 and SP-D compared with baseline at 48 weeks; | — |
Countries
China
Contacts
Public ContactQiao Ye
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed