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Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487809
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment
Asthma 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children
Actual Study Start Date : October 22, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Budesonide

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

SHH
Shuang Ho 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




Primary Outcome Measures :
  1. FEV1 [ Time Frame: 1 month ]
    change of forced expiratory volume at one second (FEV1) from baseline


Secondary Outcome Measures :
  1. PEF [ Time Frame: 1 month ]
    change of peak expiratory flow (PEF) from baseline

  2. Asthma control test [ Time Frame: 1 month ]
    change of subjective symptoms of asthma

  3. Serum biomarkers [ Time Frame: 3 months ]

    change of ICS response related serum biomarkers (S100 calcium binding protein A12, eosinophil-derived neurotoxin, signal-regulatory protein alpha

    ..)


  4. exhaled nitric oxide (eNO) [ Time Frame: 1 month ]
    change of exhaled nitric oxide

  5. exhaled nitric oxide (eNO) [ Time Frame: 3 months ]
    change of exhaled nitric oxide


Biospecimen Retention:   Samples With DNA
Blood, peripheral blood mononuclear cell (PBMC), DNA, RNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487809


Contacts
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Contact: Yungling Lee, Professor 886-2-3366-8016 leolee@ntu.edu.tw

Locations
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Taiwan
NTUH Recruiting
Taipei, Taiwan
Contact: Yungling Lee, Professor    886-2-33668016      
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yungling Lee, Professor NTUH

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03487809    
Other Study ID Numbers: 201302019RIND
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Share with other researchers majored in asthma pharmacogenetic study

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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
Keywords provided by National Taiwan University Hospital:
Asthma
Inhaled corticosteroid
pharmacogenomics
Therapeutic effect
Additional relevant MeSH terms:
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Asthma
Respiratory Aspiration
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Pathologic Processes
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists