NCT03487809

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2022

Enrollment Period

9.2 years

First QC Date

March 19, 2018

Last Update Submit

September 19, 2023

Conditions

Asthma

Keywords

AsthmaInhaled corticosteroidpharmacogenomicsTherapeutic effect

Outcome Measures

Primary Outcomes (1)

  • FEV1

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

    1 month

Secondary Outcomes (5)

  • PEF

    1 month

  • Asthma control test

    1 month

  • Serum biomarkers

    3 months

  • exhaled nitric oxide (eNO)

    1 month

  • exhaled nitric oxide (eNO)

    3 months

Study Arms (3)

NTUH

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

Drug: Budesonide/Cisclesonide

FJUH

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

Drug: Budesonide/Cisclesonide

CGH

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

Drug: Budesonide/Cisclesonide

Interventions

Budesonide/CisclesonideDRUG

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

CGHFJUHNTUH

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Asthmatic children with mild to moderate severity, tolerable with inhaled corticosteroid device, can receive blood check.

You may qualify if:

  • Diagnosed by asthma specialists, the age of onset was under 10 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, peripheral blood mononuclear cell (PBMC), DNA, RNA

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yungling Lee, Professor

    NTUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yungling Lee, Professor

CONTACT

886-2-26523013leolee@ibms.sinica.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

April 4, 2018

Study Start

October 22, 2016

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 21, 2023

Record last verified: 2022-08

Locations

TW(1)