Chronic obstructive pulmonary disease
Conditions
Interventions
Treatment group 1:Administered once, bitter tea saponin A at a dose of 300 µg
Treatment group 2:Administered once, bitter tea saponin A at a dose of 600 µg
Treatment group3:Administered twice, each time with 300 µg of bitter tea saponin A
Treatment group4:Administered twice, each time with 600 µg of bitter tea saponin A
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The subjects fully understands the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily agrees to participate as a subject, and has signed the informed consent form prior to the initiation of any study procedures; 2.Aged 40–70 years (inclusive of 40 and 70 years), regardless of gender; 3.Diagnosed with moderate COPD (at screening, post-bronchodilation with 400 µg salbutamol, FEV1% predicted >=50% to <80% within 15–30 minutes, and FEV1/FVC ratio <0.7); 4.Pre-screening medication: stable use for at least two months, such as bronchodilators (LABA, LAMA, theophylline) or medium-dose ICS + LABA; 5.The subject (including male subjects) has no pregnancy plans from screening until six months after the last dose, voluntarily adopts effective contraceptive measures, and has no plans for sperm or egg donation; 6.Demonstrates good comprehension and cooperation during the trial, and after training, the subject is capable of correctly using the nebulizer device or inhalation drug delivery device;
Exclusion criteria
Exclusion criteria: 1.History of allergy to ethanol, Tween, Kuding tea, or foods containing Kuding tea ingredients; or history of drug/food allergies deemed by the investigator as unsuitable for trial participation; 2.Current pulmonary diseases other than COPD, including a-1 antitrypsin deficiency, pneumoconiosis, cor pulmonale, asthma, bronchiectasis, hypersensitivity pneumonitis, active tuberculosis, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, interstitial lung disease, allergic bronchopulmonary aspergillosis, or lung cancer; prior pneumonectomy; or lung volume reduction surgery within 12 months before screening; or clinically significant chest CT abnormalities not attributable to COPD; 3.Respiratory infections (upper or lower tract) within 6 weeks before screening or between screening and enrollment visits; or COPD exacerbation/hospitalization within 3 months before screening or between screening and enrollment (emergency room stays >24 hours considered hospitalization); or participation in pulmonary rehabilitation programs within 4 weeks before screening or planned participation during the trial; 4.Severe cardiovascular conditions including unstable ischemic coronary disease, cardiac function class II-IV, arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, frequent premature ventricular contractions, II-III degree AV block), QTc>=480ms, bradycardia (heart rate =160mmHg or diastolic BP >=100mmHg on >=2 consecutive readings) that may pose risks or confound results per investigator assessment; 5.Hepatic/renal impairment: ALT or AST >2×ULN, ALP >1.5×ULN, TBIL >1.5×ULN, or CRE >1.5×ULN; 6.Severe hematologic, digestive, neurologic, endocrine/metabolic disorders, or malignancies (except cured in-situ cervical cancer/squamous or basal cell skin cancer with >5-year disease-free survival); or other conditions potentially affecting drug absorption/metabolism or safety/efficacy assessments per investigator judgment; 7.History of narrow-angle glaucoma, benign prostatic hyperplasia, or bladder neck obstruction poorly controlled despite therapy, where anticholinergic use is contraindicated per investigator; 8.Inability to discontinue theophyllines, LAMA, LABA, oral/inhaled corticosteroids, SAMA, or SABA >=48 hours before baseline pulmonary function testing (Day 1); 9.Current use of ICS/LABA/LAMA triple therapy; 10.Need for ß-blockers (including ophthalmic formulations) during the trial; 11.Positive serology for HBsAg, HCV antibody, treponemal antibody, or HIV; 12.Alcohol abuse (>14 units/week within 6 months prior; 1 unit of alcohol ˜ 360 mL beer/45mL 40% spirits/150mL wine) or inability to abstain during the trial; 13.Inability to cease smoking during the trial; 14.Known drug abuse history within 1 year; 15.Pregnancy, lactation, or positive pregnancy test; 16.Participation in other drug/device trials within 1 month prior to dosing; 17.Planned surgery during the study period; 18.Other investigator-determined exclusions (e.g., health status, geographical constraints) potentially compromising protocol compliance (e.g., visit schedule, pulmonary function tests);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in forced expiratory volume in one second (FEV1) at each post-dose pulmonary function assessment time point;FVC;FEV1/FVC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxygen Saturation;Electrocardiogram; | — |
Countries
China
Contacts
Public ContactZhang Min;Ding Xueying
Shanghai General Hospital
Outcome results
None listed