Childhood Asthma
Conditions
Keywords
childhood asthma, inhaled corticosteroids, Chinese medicine, Ma-Hsing-Kan-Shih-Tang, Liu-Jun-Zi-Tang
Brief summary
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
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.
Interventions
DRUGCM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)
CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) for 12 weeks
DRUG10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)
10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 90% starch for 12 weeks
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of Childhood Asthma Control Test (cACT) | week 12 | cACT questionnaire is a tool to evaluate asthma symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of the ECP | week 12 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. |
| The change of IL-5 | week 12 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. |
| The change of IL-13 | week 12 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. |
| The change of scores of the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) | week 12 | ITG-CASF is a tool to measure symptoms and disability in pediatric asthma patients |
| The change of scores of Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | week 12 | PACQLQ is designed to measure the limitations and anxieties faced by caregivers of children with asthma. |
| The change of FEV1/FVC (%) in spirometry | week 12 | 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. |
| The change of CBC/DC | week 12 | Blood test includes , total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. |
| The change of total IgE | week 12 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. |
| The change of IL-4 | week 12 | Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The change of the renal function test | week 12 | Renal function test including BUN and Creatinine will to evaluate the safety of CM usage |
| The change of the liver function test | week 12 | Liver function test including AST and ALT will to evaluate the safety of CM usage |
| Adverse drug reaction (ADR) during study period | week 12 | ADR during study period will be recorded in asthma diary. |
| The frequency of acute exacerbation | week 12 | The frequency of acute exacerbation such as ER visit and admission will be recorded in asthma diary. |
Countries
Taiwan
Contacts
Primary ContactChieh Wang
Outcome results
None listed