Clinical trial NCT03487809: Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children
Official title: Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: Asthma
Inhaled corticosteroid
pharmacogenomics
Therapeutic effect
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Academia Sinica, Taiwan
First posted: 2018-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthmatic children with mild to moderate severity, tolerable with inhaled corticosteroid device, can receive blood check.

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.

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

Primary outcomes:
measure: FEV1
timeFrame: 1 month
Secondary outcomes:
measure: PEF
timeFrame: 1 month
measure: Asthma control test
timeFrame: 1 month
measure: Serum biomarkers
timeFrame: 3 months
measure: exhaled nitric oxide (eNO)
timeFrame: 1 month
measure: exhaled nitric oxide (eNO)
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: NTUH
name: Yungling Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References: