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This study evaluates the efficacy and safety of tetrandrine tablets (60 mg, three times daily) compared to placebo in adult patients with connective tissue disease-related interstitial lung disease. Patients receive standard treatment (glucocorticoids and immunosuppressants) alongside the study drug or placebo for 24 weeks. The study measures changes in lung function, inflammatory markers, lung imaging, quality of life, and safety outcomes.
This multicenter, randomized, double-blind, placebo-controlled study enrolls 100 adults with connective tissue disease-related interstitial lung disease. Patients are randomized 1:1 to receive tetrandrine tablets (60 mg TID) or placebo for 24 weeks, alongside standard treatment. The primary outcome is the change in forced vital capacity (FVC) at 24 weeks. Secondary outcomes include changes in serum inflammatory markers (TGF-β1, KL6, TNF-α, IL-6), lung HRCT scores, other Lung function parameters (TLC, VC, DLCO, PaO2), St. George's Respiratory Questionnaire (SGRQ) score, safety parameters, and all-cause mortality. Visits occur at weeks 4, 8, 12, and 24 for efficacy and safety assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetrandrine Group | Experimental | Participants receive tetrandrine tablets (60 mg, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants). |
|
| Placebo Group | Placebo Comparator | Participants receive placebo tablets (mimicking tetrandrine, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetrandrine Tablets | Drug | 60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Vital Capacity (FVC) | Change in forced vital capacity (FVC) expressed in liters (L) of predicted normal value, measured using a pulmonary function testing device in accordance with ATS/ERS standards at a central facility. Units: Absolute value（L） | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Transforming Growth Factor Beta 1 (TGF-β1) Level | Serum TGF-β1 levels measured via fully automated analyzer. Units: ng/mL | Baseline to 24 weeks |
| Change in Serum Krebs von den Lungen-6 (KL6) Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C009438 | tetrandrine |
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| Placebo | Drug | Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants |
|
Serum KL6 levels measured via fully automated analyzer. Units: U/mL
| Baseline to 24 weeks |
| Change in Serum Tumor Necrosis Factor Alpha (TNF-α) Level | Serum TNF-α levels measured via fully automated analyzer. Units: pg/mL | Baseline to 24 weeks |
| Change in Serum Interleukin-6 (IL-6) Level | Serum IL-6 levels measured via fully automated analyzer. Units: pg/mL | Baseline to 24 weeks |
| Change in Semi-Quantitative High-Resolution Computed Tomography (HRCT) Score | Semi-quantitative scoring of HRCT patterns (reticulation, ground-glass opacity, patchy/consolidation, honeycombing) across 6 predefined lung layers. Each pattern scored 0 (absent) to 4 (>75% involvement); total score summed (maximum 96). Higher scores indicate worse outcome (greater lung involvement). Units: Score (0-96) | Baseline to 24 weeks |
| Change in Total Lung Capacity (TLC) | TLC measured via body plethysmography (ATS/ERS standards) at central facility. Units: Absolute value（L） | Baseline to 24 weeks |
| Change in Vital Capacity (VC) | VC measured via spirometry (ATS/ERS standards) at central facility. Units: Absolute value（L） | Baseline to 24 weeks |
| Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Single-breath DLCO (hemoglobin-corrected) measured via ATS/ERS standards at central facility. | Units: Absolute value（L） |
| Change in Arterial Partial Pressure of Oxygen (PaO2) | PaO2 from arterial blood gas (at rest, room air). Units: mmHg | Baseline to 24 weeks |
| Change in St. George's Respiratory Questionnaire (SGRQ) Total Score | Change in total score from Chinese-validated SGRQ (self-administered, 3-month recall), assessing respiratory health-related quality of life across Symptoms, Activity, and Impacts domains (weighted). Scores range from 0 (no impairment/best quality of life) to 100 (maximum impairment/worst quality of life). Higher scores indicate worse outcome. Units: Score (0-100) | Baseline to 24 weeks |
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Incidence of treatment-related adverse events (any untoward event post-randomization), graded by CTCAE v5.0 (coded via MedDRA). Includes abnormalities in hematology, chemistry, urinalysis, liver/kidney function. Units: Number of cases | Baseline to 24 weeks |
| Number of Participants with Treatment-Emergent Serious Adverse Events | Incidence of serious adverse events as assessed by CTCAE v5.0. Units: Number of cases | Baseline to 24 weeks |
| Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) | Incidence of clinically significant ECG abnormalities (e.g., QTc prolongation) from 12-lead ECGs. Units: Number of cases | Baseline to 24 weeks |
| Number of Participants with All-Cause Mortality | Number and percentage of participants who died from any cause during the study period (all-cause mortality), ascertained via follow-up and vital status checks. Units: Number of cases | Baseline to 24 weeks |