Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

NCT ID: NCT03487809

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-22
• Study Completion Date: 2025-12-31

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NTUH

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

Budesonide/Cisclesonide

Intervention Type: DRUG

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)

Budesonide/Cisclesonide

Intervention Type: DRUG

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)

Budesonide/Cisclesonide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academia Sinica, Taiwan

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yungling Lee, Professor

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

NTUH

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yungling Lee, Professor

Role: CONTACT

leolee@ibms.sinica.edu.tw

886-2-26523013

Facility Contacts

Yungling Lee, Professor

Role: primary

leolee@ibms.sinica.edu.tw

886-2-26523013

Other Identifiers

201302019RIND

Identifier Type: -

Identifier Source: org_study_id