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

Childhood Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066841
• Other study ID #: CMUH109-REC2-111
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2021
• Source: China Medical University Hospital
• Contact: Chieh Wang
• Phone: +886963619537
• Email: u9923035[@]cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

Drug:
• CM (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
• 10% 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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The frequency of acute exacerbation	The frequency of acute exacerbation such as ER visit and admission will be recorded in asthma diary.	week 12
Other	Adverse drug reaction (ADR) during study period	ADR during study period will be recorded in asthma diary.	week 12
Other	The change of the renal function test	Renal function test including BUN and Creatinine will to evaluate the safety of CM usage	week 12
Other	The change of the liver function test	Liver function test including AST and ALT will to evaluate the safety of CM usage	week 12
Primary	The change of Childhood Asthma Control Test (cACT)	cACT questionnaire is a tool to evaluate asthma symptoms	week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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