Tetrandrine for lung disease linked to connective tissue disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University Third Hospital
  Beijing, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Finger vs. Earlobe Pulse Oximetry During a 6-Minute Walk Test in ILD

  This study tests whether finger or earlobe pulse oximetry gives the same oxygen saturation readings during a 6-minute walk in people with interstitial lung disease.

  Recruiting Hospital de Granollers · Granollers, Spain · NCT07723872

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Tele-Pulmonary Rehabilitation for Chronic Lung Diseases

  This study tests whether a remote tele-rehabilitation program helps people with chronic lung diseases start and stick with pulmonary rehab better than usual center-based care.

  Recruiting at 2 sites Tel-Aviv Sourasky Medical Center · Ashkelon and 1 other locations · NCT07666841

• Breathlessness in respiratory diseases: who feels it and why

  This study tests how physiology, psychology, function, and breathing patterns relate to breathlessness in people with respiratory conditions compared with healthy controls.

  Recruiting University Hospitals, Leicester · Leicester, Leicestershire · NCT07648082

• Non-invasive tests to help ILD diagnosis and prognosis in pigeon fanciers and ILD patients

  Aims to see if easy blood and breath tests can help diagnose and predict outcomes for interstitial lung disease, starting with pigeon fanciers at risk and then extending to ILD patients.

  Recruiting at 3 sites University of Dundee · Blackpool and 2 other locations · NCT07615504

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.