Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

Asthma Clinical Trial

Official title:

Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03487809
• Other study ID #: 201302019RIND
• Status: Recruiting
• Start date: October 22, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: National Taiwan University Hospital
• Contact: Yungling Lee, Professor
• Phone: 886-2-26523013
• Email: leolee[@]ibms.sinica.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Taiwan	NTUH	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Academia Sinica, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1	change of forced expiratory volume at one second (FEV1) from baseline	1 month
Secondary	PEF	change of peak expiratory flow (PEF) from baseline	1 month
Secondary	Asthma control test	change of subjective symptoms of asthma	1 month
Secondary	Serum biomarkers	change of ICS response related serum biomarkers (S100 calcium binding protein A12, eosinophil-derived neurotoxin, signal-regulatory protein alpha; ..)	3 months
Secondary	exhaled nitric oxide (eNO)	change of exhaled nitric oxide	1 month
Secondary	exhaled nitric oxide (eNO)	change of exhaled nitric oxide	3 months