cough-variant asthma
Conditions
Interventions
Guominkang Granules:Guominkang Granules for oral use + Budesonide/Formoterol Powder Inhaler as needed
Conventional treatment group:Budesonide/Formoterol Powder Inhaler as needed
Sponsors
Beijing University of Chinese Medicine Third Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for cough-variant asthma; (2) Meets the diagnostic criteria for constitutional wind-disorder with qi reversal syndrome in traditional Chinese medicine; (3) Age range: 18 years = age = 70 years; (4) No restriction on sex; (5) Volunteer subjects with good compliance and signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with comorbid respiratory infections, chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, eosinophilic-related lung diseases, or other respiratory system diseases; (2) Patients with comorbid acute exacerbations of allergic rhinitis, eczema, urticaria, or other allergic diseases; (3) Patients with allergies to the following drugs/ingredients: components of traditional Chinese medicine, budesonide, formoterol, or other drugs used in this study; (4) Patients with severe primary diseases of the circulatory, digestive, urinary, endocrine, immune, or hematopoietic systems, or in the active phase of such diseases; patients with severe mental disorders or malignant tumors; or patients with clinical test indicators meeting any of the following conditions: alanine aminotransferase or aspartate aminotransferase >1.5 times the upper limit of normal; creatinine > upper limit of normal; or other abnormal laboratory findings deemed unsuitable for participation in this trial by the investigator; (5) Women in the preconception, pregnancy, or lactation periods; (6) Patients unable to complete relevant assessments, including pulmonary function tests, exhaled nitric oxide (FeNO), blood-related, as well as cough visual analog scale (VAS) scoring, cough symptom scale (CSS) scoring, Leicester Cough Questionnaire (LCQ) scoring, traditional Chinese medicine (TCM) syndrome scoring, and TCM constitution scoring; (7) Patients who have orally taken corticosteroids or other immunosuppressants within 4 weeks, or have used biologics or intravenous corticosteroids within 12 weeks; (8) Patients currently participating in other drug clinical trials or who have participated in other clinical trials within the past 4 weeks; (9) Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate during remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate during follow-up period;First recurrence time;Dosage of inhaler use;Leicester Cough Questionnaire;Cough Symptom Score;Cough evaluation test score;Newcastle laryngeal hypersensitivity questionnaire;Cough Hypersensitivity Assessment Test;Traditional Chinese Medicine constitution score;Fractional exhaled nitric oxide (FeNO);Pulmonary ventilation function;Total IgE; | — |
Countries
China
Contacts
Public ContactCui Hongsheng
Beijing University of Chinese Medicine Third Affiliated Hospital
Outcome results
None listed