Acute Exacerbation of COPD Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 40–85 years 2. Confirmed diagnosis of COPD according to GOLD 2026 guidelines, with an acute exacerbation necessitating hospitalization (defined by an acute onset of respiratory symptoms—dyspnea, increased sputum volume, or purulent sputum—exceeding daily variations) 3. GOLD classification 1–4 4. Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Respiratory failure requiring invasive mechanical ventilation 2. Concomitant diagnosis of asthma, bronchiectasis, or active pulmonary tuberculosis 3. Severe comorbidities, including unstable cardiovascular disease, malignancy, or end-stage renal/hepatic failure 4. History of severe allergic reaction to the study drug 5. Inability to comply with the 7-day treatment protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to clinical symptom recovery measured using an investigator-conducted clinical assessment (evaluating dyspnea relief, normalised sputum volume, and stable cough status) at randomisation (baseline) and day 14; participants who fail to meet recovery criteria by day 14 will be right-censored at day 14 | — |
Countries
China