Tetrandrine for lung disease linked to connective tissue disorders
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Tetrandrine Tablets in Treating Interstitial Lung Disease Related to Connective Tissue Disease
This study tests whether tetrandrine tablets (60 mg three times daily), given with usual steroid or immunosuppressant treatment, can improve lung function in adults with connective tissue disease–related interstitial lung disease over 24 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07319598 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled Phase 4 study enrolls 100 adults with connective tissue disease–related interstitial lung disease who are on stable glucocorticoid or immunosuppressant therapy. Participants are randomized 1:1 to receive tetrandrine 60 mg three times daily or matching placebo for 24 weeks in addition to their standard treatment. The primary endpoint is change in forced vital capacity (FVC) at 24 weeks; secondary outcomes include serum inflammatory markers (TGF-β1, KL6, TNF-α, IL-6), HRCT scores, additional lung function measures (TLC, VC, DLCO, PaO2), SGRQ quality-of-life scores, safety measures, and mortality. Study visits for efficacy and safety occur at weeks 4, 8, 12, and 24.
Who should consider this trial
Good fit: Adults aged 18–80 with connective tissue disease‑related interstitial lung disease meeting diagnostic criteria, FVC ≥40% predicted, on stable doses of prednisone (≤20 mg/day equivalent) or immunosuppressants for at least 4 weeks, and willing to use effective contraception are ideal candidates.
Not a fit: Patients with very advanced lung impairment (FVC <40% predicted), recent use of tetrandrine or other antifibrotic drugs, uncontrolled diabetes (fasting glucose >11.1 mmol/L), or other trial exclusions are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If effective, tetrandrine could slow or stabilize lung function decline, reduce lung inflammation and scarring, and improve symptoms and quality of life for people with CTD‑ILD.
How similar studies have performed: While several approved antifibrotic agents have shown benefit in various forms of ILD, published clinical evidence specifically supporting tetrandrine for CTD‑ILD is limited, making this a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who voluntarily participate and sign the informed consent form * Male or female patients aged 18-80 years (inclusive) * Patients meeting the diagnostic criteria for connective tissue disease-related interstitial lung disease per the 2018 Chinese Expert Consensus at screening * FVC ≥40% of predicted value at screening * Fertile male or female patients must agree to use effective contraception from signing informed consent until 3 months after the last study drug dose (Exemptions: postmenopausal women \>50 years with amenorrhea for \>1 year, or surgically sterilized women) * Patients on stable doses of prednisone (≤20 mg/day or equivalent) or immunosuppressants for at least 4 weeks prior to study entry, with dose adjustments not exceeding this during the double-blind period Exclusion Criteria: * Treatment with tetrandrine or other antifibrotic drugs within 1 month before screening * Diabetes with fasting blood glucose greater than 11.1 mmol per L * Resting arterial oxygen partial pressure less than 50 mmHg * Active peptic ulcers or bleeding disorders * Tumors with expected survival less than 1 year * Active pulmonary tuberculosis * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 5 times the upper limit of normal (ULN) or higher, or ALT or AST 3 times ULN or higher with total bilirubin 2 times ULN or higher * Creatinine clearance less than 30 mL per min (per Cockcroft-Gault formula) or patients receiving dialysis * Known allergy to tetrandrine or its excipients * Severe psychological, mental, cognitive, or intellectual impairments that may affect compliance * Pregnant or breastfeeding women, or those planning pregnancy within 3 months after the last study drug dose * Participation in another clinical trial within 3 months before screening * Patients deemed unsuitable for the study by the investigator * Clinically significant environmental exposure history that may cause pulmonary fibrosis (e.g., amiodarone, asbestos, beryllium, radiation)
Where this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.