Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Experimental group:Shiwei Longdanhua Capsule+basic care
Control group:Shiwei Longdanhua Capsule-matching placebo+basic care
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 40–80 years (inclusive) at screening. 2. Documented COPD diagnosis per GOLD criteria. 3. Spirometry within 12 months showing GOLD stage 1–3 (FEV1 >=30 % predicted). 4. Mild-to-moderate acute exacerbation of COPD (AECOPD). 5. Traditional Chinese-medicine syndrome: phlegm-heat obstructing the lung. 6. BCSS score >= 6 at screening. 7. Onset of current AECOPD <= 7 days before randomisation. 8. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Systemic or high-dose inhaled corticosteroids for the present AECOPD: – budesonide nebuliser >4 mg/day, fluticasone propionate nebuliser >2 mg/day, or beclometasone dipropionate nebuliser >4.8 mg/day. 2. Any other respiratory disorder that may cause dyspnoea, cough or sputum (e.g. asthma, bronchiectasis, active pulmonary tuberculosis, bronchiolitis obliterans, diffuse panbronchiolitis). 3. Major concomitant lung pathology (interstitial pulmonary fibrosis, lung resection, pulmonary tumour, etc.). 4. Significant cardiac disease: NYHA Class III–IV congestive heart failure (see Appendix 1); haemodynamically relevant arrhythmia or valvular abnormality; unstable angina or myocardial infarction within 6 months before screening. 5. Laboratory values at screening: ALT >2×ULN, AST >2×ULN, or Scr >1.5×ULN. 6. History of severe neurological, haematological, gastrointestinal or cerebrovascular disease, drug/alcohol abuse, or malignancy (except adequately treated cervical carcinoma in situ, non-metastatic cutaneous squamous-cell carcinoma, or basal-cell carcinoma) that in the investigator’s opinion could interfere with the study. 7. Use of any Chinese herbal medicine, Chinese patent medicine, ethnic medicine, or traditional Chinese/ethnic therapies (acupuncture, tuina, etc.) for respiratory disease within 7 days before screening. 8. Known hypersensitivity to any component of the investigational product. 9. Pregnant or lactating women; women of child-bearing potential who plan to become pregnant within 6 months after screening; women with a positive urine pregnancy test; or men planning to conceive or donate sperm during the same period. 10. Participation in another clinical drug trial within 3 months before screening. 11. Any condition that in the investigator’s opinion renders the patient unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BCSS (breathlessness, cough, and sputum score) at Day 14.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily change from baseline in total BCSS score and each individual item score, together with the area under the curve (AUC).;Daily change from baseline in EXACT-PRO score and the area under the curve (AUC).;Change from baseline in peak expiratory flow (PEF) at Day 7 and Day 14.;Change from baseline in Traditional Chinese Medicine (TCM) syndrome score at Day 14.;Time to disease resolution and disease-resolution rates at Day 7 and Day 14.;Proportion of patients progressing to severe disease at Day 7, Day 14, and Day 28, calculated separately for: ICU admission;Hospitalisatio;Respiratory failure;Overall composite (any of the above);Incidence of recurrent AECOPD from end-of-treatment to end-of-follow-up.;At Day 7 and Day 14: ? Proportion of patients receiving antibiotics, together with mean/median days of use; ? Proportion of patients receiving systemic or inhaled corticosteroids, together with cumulative dose and mean/median days of use; | — |
Countries
China
Contacts
Public ContactZheng Jinping
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed