Skip to main content
Clinical Trials/NCT03487809
NCT03487809
Recruiting
Not Applicable

Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

National Taiwan University Hospital1 site in 1 country100 target enrollmentOctober 22, 2016

Overview

Phase
Not Applicable
Intervention
Budesonide/Cisclesonide
Conditions
Asthma
Sponsor
National Taiwan University Hospital
Enrollment
100
Locations
1
Primary Endpoint
FEV1
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2016
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

NTUH

National Taiwan University Hospital, all participants receive Duasma (budesonide, 200mcg/puff)

Intervention: Budesonide/Cisclesonide

FJUH

Fu Jen University Hospital, all participants receive Duasma (budesonide, 200mcg/puff)

Intervention: Budesonide/Cisclesonide

CGH

Cathay General Hospital, all participants receive Alvesco (Ciclesonide, 160mcg/puff)

Intervention: Budesonide/Cisclesonide

Outcomes

Primary Outcomes

FEV1

Time Frame: 1 month

change of forced expiratory volume at one second (FEV1) from baseline

Secondary Outcomes

  • Asthma control test(1 month)
  • exhaled nitric oxide (eNO)(3 months)
  • PEF(1 month)
  • Serum biomarkers(3 months)

Study Sites (1)

Loading locations...

Similar Trials