Cough Variant Asthma
Conditions
Keywords
cough variant asthma, traditional Chinese medicine, clinical trial
Brief summary
To explore the disease outcome prognosis of cough variant asthma by observing the outcomes of cough variant asthma and the effects of Chinese and Western medicine interventions, and to provide a scientific basis for optimizing the treatment protocol of combined traditional and Western medicine for cough variant asthma. This is a multi-center, non-randomized, prospective cohort study. This study started in March 2022 and is going on now. On an informed consent basis, a cohort of 164 patients with diagnosis of CVA are engaged. All patients will receive 8-week treatment (ICS/LABA plus Chinese herbal medicine for trial group while ICS/LABA only for control group) and be observed in next 24 weeks. Patients will be followed up every 2 weeks during treatment period and every 4 weeks in observation.The feasibility and correctness of the study will be supervised by two supervisors. To ensure that participants adhere to their follow-up plans, we remind them of their fixed visiting by phone or message. Additionally, incentives are used to appreciate participants for their cooperation.
Interventions
DRUGtraditional chinese medicine Xuanfei-Zhike formula
200ml, bid, for 8 weeks
DRUGinhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)
one suction, q12h, for 8 weeks
Sponsors
Xin Hua Hospital of Zhejiang Province
Hangzhou Hospital of Traditional Chinese Medicine
Affiliated Wenling Hospital of Wenzhou Medical University
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. conform to diagnosis of CVA; 2. 18 years≤age≤65 years; 3. agree to participant in this trial.
Exclusion criteria
1. comorbidity of respiratory and pulmonary infections; 2. history of mental illness; 3. comorbidity of heart and cardiovascular, liver, kidney and hematopoietic function and other severe diseases; 4. participants of other clinical trials who may make a difference in our trial; 5. treatment with other Chinese herb.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total effective rate calculated by the Cough-related Symptom Scale | week 8 | Cough-related Symptom Scale is specially designed for this trial. Question1-5 in CSS comes from Chinese national guideline on diagnosis and management of cough (2021) and the rest questions are set based on clinical experience and other study . Total effective rate can be directly reflected in Efficacy Index (EI) which set by National Medical Products Administration . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in Cough severity visual analogue scale | baseline and week 8 ,baseline and week 32 | Cough severity visual analogue scale (VAS) is used to record participants' assessments of cough severity. It is shown as a 0-mm to 100-mm liner scale ranging from no cough to severe cough. The bigger score represents more severe cough. |
| change from baseline in Leicester Cough Questionnaire | baseline and week 8 ,baseline and week 32 | Leicester Cough Questionnaire, as a useful tool in clinical trial, consists of 19 items which is a repeatable, valid self-evaluated quality of life measure of chronic cough and responsive to change . |
| change from baseline in Pulmonary function | baseline and week 8 ,baseline and week 32 | Pulmonary function test reveals some details of a patient's condition in respiratory function, like forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, peak expiratory flow (PEF), forced expiratory flow 25% (FEF25), forced expiratory flow 75% (FEF75), forced expiratory flow between 25% and 75% of forced vital capacity (FEF(25-75)) etc. |
| change from baseline in Cough-related Symptom Scale | baseline and week 8 ,baseline and week 32 | This scale consists of two parts. Question1-5 come from Chinese national guideline on diagnosis and management of cough (2021) to evaluate the symptom of cough. Question6-10 are some accompanying performances, including cough-stimulated factors like wind, cold air, smoking etc, sputum, sensations of persistent tickling, thirsty, Qi inversion in throat. |
| the ratio of progressing to typical asthma from week 8 to week 32 | week 32 | the ratio of progressing to typical asthma is characterized as the ratio of participants who turning from CVA into classic asthma based on Guidelines for bronchial asthma prevent and management (2020 edition) during 6-month observation. |
| change from baseline in fractional exhaled nitric oxide | baseline and week 8 ,baseline and week 32 | Nitric oxide (NO) is produced by inducible nitric oxide synthase (iNOS) in airway epithelial cells and FENO is associated with eosinophilic airway inflammation which usually indicates the sensitivity to ICS. |
| change from baseline in Serum IgE | baseline and week 8 ,baseline and week 32 | IgE is linked to its ability to affect several immune and structural cells involved in allergic asthma. |
| CVA recurrence rate from week 8 to week 32 | week 32 | CVA recurrence rate is defined as the occurance rate of similar cough which conforms to CVA diagnosis criteria during 6-month observation. |
Countries
China
Contacts
Primary ContactJunchao Yang
Outcome results
None listed