Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

Study Overview
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Brief Summary
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Inhaled corticosteroid (ICS) is considered the first line medication for asthma, however, the therapeutic effect is markedly different even in patients with almost similar clinical manifestations. Our study was designed to explore the clinical and genetic factors that may influence the effectiveness of ICS in asthmatic children.

Detailed Description
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The three major common classes of asthma controller medications include inhaled corticosteroids (ICS), beta-2-agonists and leukotriene antagonists. Among them, ICS was now suggested as the first-line therapy demonstrated in Global Initiative for Asthma guideline updated in 2017. The response to asthma medication is markedly different even in patients with almost similar clinical manifestations. Despite the wide availability of therapeutic asthma medications and large studies supporting their efficacy, there is significant inter-personal variability in the response to each of the three major classes of asthma medications with a subgroup of patients that have limited disease control, persistent symptoms and exacerbations even under controller medications use. For example, inter-individual variability in therapeutic effectiveness to ICS in both asthma children and adults is significant, with 22 to 60% of patients being classified as non-responders. Although many factors can contribute to variation in response to therapy effectiveness, such as higher exhaled nitric oxide, higher total eosinophil counts, higher immunoglobulin E, lower forced expiratory volume at one second (FEV1) predicted. and lower concentration of methacholine needed to produce a 20% fall in FEV1 from baseline (PC20), it is still believed that genetic variability can also play an important role. Hence asthma represents a major burden with respect to mortality, morbidity and National Health Insurance costs, searching for appropriate mediations for asthma control is imperative and investigating the effect of genetic variability on therapy response is an important step to develop personalized prescription.

Official Title
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Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/Cisclesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed by asthma specialists, the age of onset was under 10 years old Exclusion Criteria: Children with cancer, major immunological diseases, such as systemic lupus erythematosus (SLE) or Henoch-Schonlein purpura (HSP), rare hereditary diseases, or under severe infection. Children who received ICS or oral steroid in recent 4 weeks

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NTUH<br>National Taiwan University Hospital, all participants receive Duasma (budesonide, 200mcg/puff) | Drug: Budesonide/Cisclesonide<br>* One arm observation study: Duasma 1 puff bid (Budesonide 200mcg bid) or Alvesco 1 puff qd (Ciclesonide 160mcg qd) for participants aged 11 years and younger, Duasma 2 puffs bid (Budesonide 400mcg bid) or Alvesco 1 puff bid(Ciclesonide 160mcg bid) for participants aged 12 years and older<br>|
| FJUH<br>Fu Jen University Hospital, all participants receive Duasma (budesonide, 200mcg/puff) | Drug: Budesonide/Cisclesonide<br>* One arm observation study: Duasma 1 puff bid (Budesonide 200mcg bid) or Alvesco 1 puff qd (Ciclesonide 160mcg qd) for participants aged 11 years and younger, Duasma 2 puffs bid (Budesonide 400mcg bid) or Alvesco 1 puff bid(Ciclesonide 160mcg bid) for participants aged 12 years and older<br>|
| CGH<br>Cathay General Hospital, all participants receive Alvesco (Ciclesonide, 160mcg/puff) | Drug: Budesonide/Cisclesonide<br>* One arm observation study: Duasma 1 puff bid (Budesonide 200mcg bid) or Alvesco 1 puff qd (Ciclesonide 160mcg qd) for participants aged 11 years and younger, Duasma 2 puffs bid (Budesonide 400mcg bid) or Alvesco 1 puff bid(Ciclesonide 160mcg bid) for participants aged 12 years and older<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | change of forced expiratory volume at one second (FEV1) from baseline | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEF | change of peak expiratory flow (PEF) from baseline | 1 month | 
| Asthma control test | change of subjective symptoms of asthma | 1 month | 
| Serum biomarkers | change of ICS response related serum biomarkers (S100 calcium binding protein A12, eosinophil-derived neurotoxin, signal-regulatory protein alpha ..) | 3 months | 
| exhaled nitric oxide (eNO) | change of exhaled nitric oxide | 1 month | 
| exhaled nitric oxide (eNO) | change of exhaled nitric oxide | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Inhaled corticosteroid, pharmacogenomics, Therapeutic effect