Connective tissue disease-related interstitial lung disease
Conditions
Interventions
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as interstitial lung disease related to connective tissue disease meet the international general diagnostic criteria; 2. Patients in stable stage with mild to moderate lung function impairment; 3. Patients aged 40-85 years; 4. patients who did not participate in the clinical study of other drugs in the past month; 5. The process of obtaining informed consent for the subjects with informed consent and voluntary consent conforms to the provisions of GCP.
Exclusion criteria
Exclusion criteria: 1. Patients with severe lung function impairment, or unable to complete lung function test; 2. Patients with other serious pulmonary diseases, such as COPD, asthma, tuberculosis, lung cancer, bronchiectasis, pulmonary hypertension, etc; 3. Patients who received lung volume reduction surgery within 12 months before previous pneumonectomy or screening; 4. Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, and mental diseases; 5. Patients who are allergic to any component of the test drug or who are allergic to more than 2 kinds of food or drugs; 6. Patients who are not considered suitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual decline rate of forced vital capacity (FVC);Number of hospital admissions with acute exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome scores;St. George's Respiratory Questionnaire;pulmonary function test (TLC, FEV1, DLco);6 minutes walk distance;Immune function indicators (proportion of T lymphocytes, humoral immune function, complement); | — |
Countries
China
Contacts
Public ContactZHAGN Hongchun
China-Japan Friendship Hospital
Outcome results
None listed