Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide/Cisclesonide

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Yungling Lee, Professor; Phone Number: 886-2-26523013; Email: leolee@ibms.sinica.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • NTUH
    • Contact: Yungling Lee, Professor; Phone Number: 886-2-26523013; Email: leolee@ibms.sinica.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Asthmatic children with mild to moderate severity, tolerable with inhaled corticosteroid device, can receive blood check.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NTUH; National Taiwan University Hospital, all participants receive Duasma (budesonide, 200mcg/puff)	Drug: Budesonide/Cisclesonide; 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
FJUH; Fu Jen University Hospital, all participants receive Duasma (budesonide, 200mcg/puff)	Drug: Budesonide/Cisclesonide; 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
CGH; Cathay General Hospital, all participants receive Alvesco (Ciclesonide, 160mcg/puff)	Drug: Budesonide/Cisclesonide; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Academia Sinica, Taiwan
• Investigators: Principal Investigator: Yungling Lee, Professor, NTUH

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2016
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Asthma; Inhaled corticosteroid; pharmacogenomics; Therapeutic effect
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: 201302019RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Share with other researchers majored in asthma pharmacogenetic study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No