Asthma–COPD Overlap
Conditions
Interventions
Control Group:Basic Western medical treatment +Xinjia Bushen Naqi Formula placebo (1packet per dose, twice daily)
Treatment group:Basic Western medical treatment +Xinjia Bushen Naqi Formula (1packet per dose, twice daily)
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) A history of being diagnosed with bronchial asthma; (2) Post-bronchodilator FEV1/FVC <70% in pulmonary function tests during the screening period or Visit 1; (3) Meeting the diagnostic criteria for deficiency of lung and kidney qi in traditional Chinese medicine; (4) Age between 18 and 75 years (inclusive), with no gender restrictions; (5) Understanding and complying with the study procedures, voluntarily participating, and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diseases with known etiology or specific pathological manifestations accompanied by airflow obstruction, such as cystic fibrosis or diffuse panbronchiolitis. 2. A history of immunodeficiency, other congenital immunodeficiency diseases, or organ transplantation. 3. Presence of severe comorbidities that may endanger patient safety or affect study completion. 4. Patients diagnosed with other infectious diseases such as tuberculosis, measles, or HIV/AIDS. 5. Patients with severe primary diseases of the heart, brain, lungs, liver, kidneys, or hematopoietic system, or with abnormal liver and kidney function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 1.5 times the upper limit of normal; serum creatinine [Scr] > 1.2 times the upper limit of normal). 6. Patients with malignant tumors. 7. Patients with a confirmed history of neurological or psychiatric disorders who, in the investigator's opinion, are unable to comply with treatment or follow medical instructions. 8. Patients with contraindications to long-acting muscarinic antagonist (LAMA) therapy, such as severe benign prostatic hyperplasia or glaucoma. 9. Known allergy to any components of the investigational Western or traditional Chinese medicines. 10. Use of oral Chinese herbal medicines or proprietary Chinese medicines within one week prior to screening. 11. Pregnant, planning to become pregnant, or lactating women. 12. History of chronic alcoholism or drug abuse within 12 months prior to enrollment, or poor compliance during screening, or any factors that may affect compliance. 13. Patients unable to comply with the study protocol or to understand the nature, scope, and consequences of the study. 14. Participation in another drug clinical trial within the past 3 months or in a medical device clinical trial within the past month. 15. Any other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this clinical trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary Function;COPD Assessment Test (CAT) score;Asthma Control Questionnaire (ACQ-6) Scoring;Peak Expiratory Flow (PEF) Variability;Dosage and Frequency of Maintenance Medications;Acute Exacerbation;FeNO;Serum immunoglobulin E;Asthma Quality of Life Questionnaire;TCM Syndrome Score; | — |
Primary
| Measure | Time frame |
|---|---|
| FEV1; | — |
Countries
China
Contacts
Public ContactLu Zhenhui
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed