Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Influenza, Human, Virus Diseases
Conditions
Keywords
COPD Exacerbation, Real-World Study, Traditional Chinese Medicine
Brief summary
The goal of this observational study is to learn if a traditional Chinese herbal medicine (Xuanfei Jiangzhuo Decoction) works to help older adults recover from a COPD flare-up caused by the flu (influenza virus). The main questions it aims to answer are: Does the herbal medicine help participants feel better and recover faster? Does it lower the chance of getting a second infection from bacteria? Is the herbal medicine safe to use? Researchers will compare participants who choose to take the herbal medicine along with their standard flu treatment (Oseltamivir or Baloxavir) to participants who only take the standard flu treatment (Oseltamivir or Baloxavir). Participants will: Take the herbal medicine (a liquid drink) twice a day for 5 days, or just take their standard flu medicine for 5 days. Visit the clinic 4 times over 28 days for checkups and tests. Provide blood and stool samples to help researchers understand how the medicine affects the body and gut health. Answer simple questions about their cough, breathing, and energy levels.
Interventions
DRUGXuanfei Jiangzhuo Decoction
A traditional Chinese medicine composite formula derived from Maxing Shigan Tang and Shengjiang San. It is administered orally as a liquid decoction, 200 mL per dose, twice daily (morning and evening, 30 minutes after meals) for 5 days.
DRUGStandard Antiviral Therapy (Oseltamivir or Baloxavir marboxil)
Patients receive standard antiviral treatment according to clinical guidelines and physician judgment. Medications include Oseltamivir (e.g., 75 mg twice daily for 5 days) or Baloxavir marboxil (singl
Sponsors
Tianjin Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Influenza-induced AECOPD according to the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD 2025) and the Expert Consensus on the Diagnosis and Treatment of AECOPD in China (Updated 2023), confirmed by spirometry and viral testing (antigen or PCR), and excluding pneumonia and heart failure via chest CT and NT-proBNP. * Aged 60 years or older. * Voluntarily participate and provide written informed consent..
Exclusion criteria
* Known allergy or hypersensitivity to any component of the study medications. * Presence of severe bacterial co-infection at enrollment requiring systemic antibiotic therapy. * Severe dysfunction of major organs that may interfere with efficacy or safety assessment (e.g., severe cardiac insufficiency, hepatic impairment, or renal failure). * Participation in other interventional clinical trials within the past 3 months. * Inability to be contacted for follow-up (e.g., lack of permanent address or valid contact information). * Any other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation (e.g., severe cognitive impairment or psychiatric disorders).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinical Remission of AECOPD | From baseline (Day 0) up to Day 28 | Defined as the duration from treatment initiation (Day 0) to the point where the mMRC dyspnea scale score returns to pre-exacerbation baseline, and both cough and dyspnea symptom scores (0-3 Likert scale) decrease by at least 1 point from the peak and remain at that reduced level for ≥ 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Defervescence | From baseline (Day 0) up to Day 14 | Defined as the time until axillary temperature is ≤ 37.4°C and maintained for 24 hours. |
| Time to Alleviation of Individual Symptoms | From baseline (Day 0) up to Day 28 | Defined as the time until individual symptom scores are ≤ 1 and maintained for 24 hours. |
| Change in COPD Assessment Test (CAT) Score | Baseline (Day 0), Day 5, Day 14, and Day 28 | The CAT measures the impact of COPD on a person's life. Scores range from 0-40, with higher scores indicating a more severe impact of the disease. |
| Rate of Secondary Bacterial Infection | From baseline (Day 0) through Day 28 | Defined as clinical worsening (recurrence of fever, increased purulent sputum) accompanied by at least one of: (1) positive sputum culture for a pathogenic bacterium, (2) procalcitonin (PCT) \> 0.25 ng/mL, or (3) radiographic evidence of new infiltrates. |
| Frequency of Rescue Medication Use | Up to Day 28 | Frequency of additional antipyretic or analgesic use during the study period. |
| Time to Next AECOPD Event | Up to Day 28 | Time from enrollment to the next confirmed acute exacerbation of COPD. |
Countries
China
Contacts
CONTACTCaiyan Jia
Outcome results
None listed