Clinical trial NCT05066841: Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Asthma
Keywords: childhood asthma
inhaled corticosteroids
Chinese medicine
Ma-Hsing-Kan-Shih-Tang
Liu-Jun-Zi-Tang
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 86
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of Childhood Asthma Control Test (cACT)
timeFrame: week 12
Secondary outcomes:
measure: The change of FEV1/FVC (%) in spirometry
timeFrame: week 12
measure: The change of CBC/DC
timeFrame: week 12
measure: The change of total IgE
timeFrame: week 12
measure: The change of the ECP
timeFrame: week 12
measure: The change of IL-4
timeFrame: week 12
measure: The change of IL-5
timeFrame: week 12
measure: The change of IL-13
timeFrame: week 12
measure: The change of scores of the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
timeFrame: week 12
measure: The change of scores of Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
timeFrame: week 12
Other outcomes:
measure: The frequency of acute exacerbation
timeFrame: week 12
measure: Adverse drug reaction (ADR) during study period
timeFrame: week 12
measure: The change of the renal function test
timeFrame: week 12
measure: The change of the liver function test
timeFrame: week 12
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: