Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children

Study Overview
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Brief Summary
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The purpose of study is to provide an objective data for evaluating the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Investigators will recruit eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage and they will be randomized into two groups in this double-blind trial. Forty-three subjects will receive CM (CM group; Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and the other forty-three subjects will receive placebo (placebo group; 10% CM) for 12 weeks. Investigators will compare these two groups by questionnaires of Childhood Asthma Control Test (cACT), the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF), Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), the pulmonary function test and blood test including Complete Blood Count with Differential Count (CBC/DC), total IgE, Eosinophil Cationic Protein (ECP) and IL-4/IL-5/IL-13. Adverse events, renal and liver function test will be evaluated to investigate the safety of CM formula as well.

Detailed Description
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Treating pediatric asthma has been in accordance with GINA guidelines by stepwise approach to adjust treatment for individual patient needs. However, most of the asthma controller medication nowadays is inhaled corticosteroids (ICS). Parents with steroid phobia may raise concern and fears about the potential systemic effects, leading to poor adherence to medication and worse control. This study aims to evaluate the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid for the treatment of mild to moderate persistent asthma in children. Investigators focus on the following specific aims: Aim 1. To determine the efficacy of the CM formula (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) compared with placebo; Aim 2. To evaluate the effects of CM formula on quality of life in these patients with pediatric asthma; Aim 3. To investigate the safety of CM formula in these patients with pediatric asthma. Eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage will be randomized into two groups in this double-blind trial. Forty-three subjects will receive CM (CM group; Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and the other forty-three subjects will receive placebo (placebo group; 10% CM) for 12 weeks. The evaluation including pulmonary function test, IOS, FeNO, blood test, questionnaire and asthma diary card of both two groups will be conducted during the study period. The safety of CM formula use will be investigated by recording the adverse events and renal and liver function test as well. This study will provide an objective data for evaluating the efficacy and safety o of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Through the combination of Chinese and western medicine, we expect to enhance the efficacy of asthma treatment, reduce acute exacerbation and tapper the dose of inhaled corticosteroids, leading to better quality of life.

Official Title
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Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children: a Randomized Double-blind Placebo-controlled Trial

Conditions
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Childhood Asthma

Intervention / Treatment
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* Drug: CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)
* Drug: 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 4-11 years old GINA (Global Initiative for Asthma) guideline belong to mild to moderate asthmatic children regular use low dose ICS+ LABA or medium dose ICS at least one month Exclusion Criteria: asthma with acute exacerbation or ever has used systemic steroids in recent one month psychiatric disease or behavior disorder ever has received Chinese herbal medicine or other traditional Chinese medicine treatment in recent two weeks

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM group<br> | Drug: CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)<br>* CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) for 12 weeks<br>|
| Placebo Comparator: placebo group<br> | Drug: 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)<br>* 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 90% starch for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Childhood Asthma Control Test (cACT) | cACT questionnaire is a tool to evaluate asthma symptoms | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of FEV1/FVC (%) in spirometry | Spirometry can be used to easily evaluate pulmonary function for children older than 6 years old. Participants who are unable to perform forced expiratory maneuvers will use Impulse Oscillometry System (IOS) instead. | week 12 | 
| The change of CBC/DC | Blood test includes , total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. | week 12 | 
| The change of total IgE | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. | week 12 | 
| The change of the ECP | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. | week 12 | 
| The change of IL-4 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. | week 12 | 
| The change of IL-5 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. | week 12 | 
| The change of IL-13 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. | week 12 | 
| The change of scores of the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) | ITG-CASF is a tool to measure symptoms and disability in pediatric asthma patients | week 12 | 
| The change of scores of Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | PACQLQ is designed to measure the limitations and anxieties faced by caregivers of children with asthma. | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood asthma, inhaled corticosteroids, Chinese medicine, Ma-Hsing-Kan-Shih-Tang, Liu-Jun-Zi-Tang