Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine

Study Overview
=================
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.

Official Title
-----------------
Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine

Conditions
-----------------
Cough Variant Asthma

Intervention / Treatment
-----------------
* Drug: traditional chinese medicine Xuanfei-Zhike formula
* Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: conform to diagnosis of CVA; 18 years≤age≤65 years; agree to participant in this trial. Exclusion Criteria: comorbidity of respiratory and pulmonary infections; history of mental illness; comorbidity of heart and cardiovascular, liver, kidney and hematopoietic function and other severe diseases; participants of other clinical trials who may make a difference in our trial; treatment with other Chinese herb.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>those receive ICS/LABA plus traditional Chinese medicine | Drug: traditional chinese medicine Xuanfei-Zhike formula<br>* 200ml, bid, for 8 weeks<br>Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)<br>* one suction, q12h, for 8 weeks<br>|
| Active Comparator: group 2<br>those receive ICS/LABA alone | Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)<br>* one suction, q12h, for 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total effective rate calculated by the Cough-related Symptom Scale | 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 . | week 8 | 
| total effective rate calculated by the Cough-related Symptom Scale | 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 . | week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in Cough-related Symptom Scale | 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. | baseline and week 8 ,baseline and week 32 | 
| change from baseline in Cough severity visual analogue scale | 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. | baseline and week 8 ,baseline and week 32 | 
| change from baseline in Leicester Cough Questionnaire | 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 . | baseline and week 8 ,baseline and week 32 | 
| change from baseline in Pulmonary function | 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. | baseline and week 8 ,baseline and week 32 | 
| CVA recurrence rate from week 8 to week 32 | CVA recurrence rate is defined as the occurance rate of similar cough which conforms to CVA diagnosis criteria during 6-month observation. | week 32 | 
| the ratio of progressing to typical asthma from week 8 to 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. | week 32 | 
| change from baseline in fractional exhaled nitric oxide | 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. | baseline and week 8 ,baseline and week 32 | 
| change from baseline in Serum IgE | IgE is linked to its ability to affect several immune and structural cells involved in allergic asthma. | baseline and week 8 ,baseline and week 32 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cough variant asthma, traditional Chinese medicine, clinical trial