TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease

NCT07295938 | Recruiting Phase 2

• 1 other identifier: 2024LCSY166
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 8

Brief Summary

Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). The investigators aimed to evaluate the efficacy of Chinese herbs as adjunct therapy to improve cure rates or reduce recurrence rates during the continuation phase of MAB-PD treatment.

Conditions

Mycobacterium Abscessus Pulmonary Disease

Keywords

Mycobacterium abscessus Pulmonary Disease; Continuation Phase; TCM

Outcome Measures

Primary Outcomes (2)

• Clinical cure rate

  Measured the change from the Baseline to the end of treatment. The sputum MAB culture was negative on three consecutive occasions, with at least a one-month interval between each, and there were no subsequent positive results.

  At the end of 52 weeks of treatment

• Relapse or reinfection rates

  Bacterial relapse is defined as the occurrence of at least two cultures and/or molecular biology tests identifying the same pathogenic M. abscessus strain as the initial infection after completing anti-M. abscessus treatment. When necessary, genotyping techniques may be employed to differentiate between relapse and reinfection. Reinfection refers to the emergence of different pathogenic strains or species in at least two positive cultures following the initiation of treatment.

  At the end of 52 weeks of treatment

Secondary Outcomes (9)

• Time to sputum culture conversion

  From baseline to 52 weeks post-treatment completion

• Absorption rate of lung lesions

  Baseline, 26 weeks and 52 weeks

• Rate of closure of lung cavities

  Baseline, 26 weeks and 52 weeks

• Pulmonary function tests

  Baseline, 26 weeks and 52 weeks

• 6 minute walking test

  Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks

Study Arms (4)

Treatment Group-I

EXPERIMENTAL

104 participants with persistently positive bacterial cultures during the continuation phase received Chinese herbal therapy in addition to the guideline-recommended regimen, with the primary endpoint being the cure rates at 52 weeks.

Drug: Chinese herbs-I

Control Group-I

PLACEBO COMPARATOR

104 participants with persistently positive bacterial cultures during the continuation phase received a placebo comprising a 1/20 dose of Chinese herbs in addition to the guideline-recommended regimen, with the primary endpoint being the cure rates at 52 weeks.

Drug: Chinese herbs-I placebo

Treatment Group-II

EXPERIMENTAL

72 participants with negative bacterial cultures during the continuation phase received Chinese herbal therapy in addition to the guideline-recommended regimen, with the primary endpoint being the relapse or reinfection rates at 52 weeks.

Drug: Chinese herbs-II

Control Group-II

PLACEBO COMPARATOR

72 participants with negative bacterial cultures during the continuation phase received a placebo comprising a 1/20 dose of Chinese herbs in addition to the guideline-recommended regimen, with the primary endpoint being the relapse or reinfection rates at 52 weeks.

Drug: Chinese herbs-II placebo

Interventions

Chinese herbs-I DRUG

This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time

Treatment Group-I

Chinese herbs-I placebo DRUG

Chinese herbs-I placebo

Control Group-I

Chinese herbs-II DRUG

This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease during the continuation phase for a long time

Treatment Group-II

Chinese herbs-II placebo DRUG

Chinese herbs-II placebo

Control Group-II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with Mycobacterium abscessus pulmonary disease;
• Patients have completed the initial phase of treatment as recommended by the guidelines;
• Patients who have given written informed consent
• One week prior to enrollment, organ function levels must meet the following criteria: a. Hemoglobin ≥60g/L; b. Neutrophil count ≥0.5×10\^9/L; c. Platelet count ≥60×10\^9/L; d. Serum total bilirubin ≤3 times the upper limit of normal; e. Aspartate aminotransferase ≤3 times the upper limit of normal; f. Alanine aminotransferase ≤3 times the upper limit of normal; g. Creatinine level below 2 times the upper limit of normal or creatinine clearance ≥60mL/min; h. Urea nitrogen ≤200mg/L; i. Urinary protein \<++, with ≥500mg total protein in 24-hour urine if protein is present; j. Blood glucose: within normal range and/or stable blood glucose control in diabetic patients; k. Cardiac function: no history of myocardial infarction within 6 months; no unstable angina; no severe arrhythmia.

You may not qualify if:

• Patients with a drug allergy to the investigational medication;
• Patients infected with two or more non-tuberculous mycobacteria, or those with active pulmonary tuberculosis;
• Patients with a prior history of pulmonary parenchymal organ transplantation;
• Patients with severe conditions such as congenital or acquired immunodeficiency disorders, active malignant tumors (primary or metastatic), or any malignancies requiring chemotherapy or radiotherapy during screening or study;
• Patients undergoing dialysis;
• Patients with radiation pneumonitis requiring corticosteroid or immunoglobulin pulse therapy, or clinically proven active interstitial lung disease, uncontrolled massive pleural effusion, or pericardial effusion;
• Unstable systemic comorbidities (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic or renal dysfunction, neuropsychiatric conditions such as Alzheimer's disease);
• Patients with intestinal dysfunction or malabsorption syndrome;
• Pregnant or breastfeeding women;
• Patients receiving other investigational drugs within 4 weeks prior to first exposure to the study drug;
• Concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or follow-up visits in interventional trials;
• Physical examinations or clinical tests that the investigator deems potentially interfering with results or increasing treatment-related complications.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Anhui Chest Hospital: collaborator
• Guangzhou Chest Hospital.: collaborator
• Jiangxi Chest Hospital: collaborator
• Beijing Chest Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Huashan Hospital: collaborator
• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (8)

Beijing Chest Hospital Affiliated to Capital Medical University

Beijing, China

NOT YET RECRUITING

China-Japan Friendship Hospital

Beijing, China

NOT YET RECRUITING

Guangzhou Municipal Hospital of Chest Medicine

Guangdong, China

RECRUITING

Anhui Provincial Chest Hospital

Hefei, China

RECRUITING

Jiangxi Chest Hospital

Nanchang, China

NOT YET RECRUITING

Fudan University Affiliated Huashan Hospital

Shanghai, China

NOT YET RECRUITING

Longhua Hospital Affiliated Shanghai University of TCM

Shanghai, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

Study Officials

• Zhenhui Lu

  Longhua Hospital

  STUDY CHAIR

Central Study Contacts

Shaoyan Zhang

CONTACT

+8621-64385700-1307; zhangshaoyan000@163.com

Zhenhui Lu

CONTACT

+8621-64385700-1307; tcmdoctorlu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a Double-blind Trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: All participants in the treatment group received the recommended treatment regimen according to guidelines, supplemented with Chinese herbs, upon study entry. In contrast, the control group received a placebo consisting of a 1/20 dose of Chinese herbs.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 22, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CN (8)