Chronic Obstructive Pulmonary Disease (Phlegm-Turbidity Obstructing Lung Syndrome)
Conditions
Interventions
Experimental Group: Basic treatment + Juhong Tanke Oral Liquid:Juhong Tanke Oral Liquid (10ml/vial): Oral, 2 vials each time, 3 times daily. Continuous treatment for 4 weeks.
Control Group: Basic treatment + Juhong Tanke Oral Liquid Placebo:Juhong Tanke Oral Liquid Placebo (10ml/vial): Oral, 2 vials each time, 3 times daily. Continuous treatment for 4 weeks.
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western diagnostic criteria for chronic obstructive pulmonary disease as per the Global Strategy for Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2025) [1] and the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revision) [2], with pulmonary function classification as GOLD1~3 (FEV1% predicted =30%). (2) Presence of sticky sputum symptoms (sputum characteristics score =2 points) and difficulty in expectoration (expectoration difficulty score =2 points) during the run-in and baseline periods. (3) Traditional Chinese Medicine (TCM) syndrome differentiation confirming phlegm-turbidity obstructing lung syndrome. (4) Age 18-75 years (inclusive), regardless of gender. (5) Participants are informed, voluntarily sign informed consent, and agree to participate in all visits, examinations, and treatments as required by the trial protocol.
Exclusion criteria
Exclusion criteria: (1) No acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 4 weeks prior to the run-in period (assessed according to the diagnostic criteria in the Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (2023) [3]). (2) Sputum expectoration difficulty caused by structural airway narrowing (e.g., respiratory tract tumors, foreign body obstruction, extrinsic airway compression). (3) Severe cardiovascular diseases (congestive heart failure classified as NYHA Class III~IV; significant arrhythmias affecting hemodynamics, or history of unstable angina or myocardial infarction within the past month). (4) Severe primary diseases of the digestive, endocrine, nervous, or hematopoietic systems, or psychiatric disorders. (5) Anticipated need for hospitalization or antibiotic treatment during the run-in or treatment periods. (6) History of cancer (except participants with cured in situ cervical cancer, cutaneous squamous cell carcinoma, or basal cell carcinoma >5 years prior). (7) Other active or clinically significant concurrent respiratory diseases that may significantly impact the study: e.g., bronchiectasis, asthma, pulmonary embolism, interstitial lung disease, active tuberculosis, lung cancer, sarcoidosis, bronchiolitis obliterans, rare a1-antitrypsin deficiency, or other active pulmonary diseases. (8) Use of leukotriene antagonists, antihistamines, antibiotics, or other antitussive/expectorant/anti-inflammatory drugs within 1 week prior to baseline. (9) Abnormal liver/kidney function test results (ALT >2×ULN, AST >2×ULN, or Scr >1.5×ULN) deemed unsuitable for enrollment by investigators. (10) Pregnant, lactating, or women planning pregnancy during the study. (11) History of allergy or hypersensitivity to trial drugs, rescue medications, or olodaterol. (12) Participation in drug clinical trials within 3 months or non-interventional trials within 1 month prior to enrollment. (13) History of chronic alcoholism, drug abuse, poor compliance during screening, or any factors affecting compliance. (14) Other conditions deemed unsuitable for trial participation by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Changes from baseline in Cough and Sputum Assessment Questionnaire (CASA-Q) scores and sub-scores, and proportion of participants with 0 score when perceiving improvement in cough/sputum;; | — |
Secondary
| Measure | Time frame |
|---|---|
| (2) Time to onset of perceived cough/sputum improvement (days from first dose);;(3) Changes from baseline in 24-hour sputum volume, sputum characteristics score, sputum viscosity score, and proportion of participants with 0 score when perceiving improvement;;(4) Area Under the Curve (AUC) for daily expectoration difficulty score, daily cough VAS score, and daily cough frequency;;(5) Changes from baseline in Cough Evaluation Test (CET) score and proportion of participants with 0 score when perceiving improvement;;(6) Changes from baseline in COPD Assessment Test (CAT) score when perceiving improvement;;(7) Changes from baseline in Leicester Cough Questionnaire (LCQ) score;;(8) Changes from baseline in modified Medical Research Council (mMRC) Dyspnea Scale score when perceiving improvement;;(9) Changes from baseline in pulmonary function parameters;;(10) Changes from baseline in TCM syndrome scores (sputum score, cough score, total score);;(11) Total effective rate of TCM syndrome treatment and effective rates for sputum and cough;;AECOPD occurrences during treatment: frequency of AECOPD, frequency of moderate-severe AECOPD, time to first AECOPD, time to first moderate-severe AECOPD;;(13) Changes from baseline in neutrophil count and eosinophil count;;Rescue medication (Salbutamol Sulfate Inhalation Aerosol) usage: daytime/nighttime/total/average daily uses;;(15) All-cause hospitalization rate and AECOPD-related hospitalization rate.; | — |
Countries
China
Contacts
Public ContactZhang Hongchun
China-Japan Friendship Hospital
Outcome results
None listed