NCT04185129

Brief Summary

This is a randomized study to compare asthma patients using Foster or Relvar.

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
200

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jan 2020

Typical duration for phase_4 asthma

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

First Submitted

Initial submission to the registry

November 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

November 28, 2019

Last Update Submit

December 3, 2019

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Lung function improvement

    FEV1

    one year

Study Arms (2)

Foster

EXPERIMENTAL

uncontrolled asthma patients were randomized into Foster treatment group

Drug: Foster

Relvar

ACTIVE COMPARATOR

uncontrolled asthma patients were randomized into Relvar treatment group

Drug: Foster

Interventions

FosterDRUG

a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation

Also known as: Relvar
FosterRelvar

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosis with asthma with treatment naive
  • asthma patients with poor controlled status

You may not qualify if:

  • COPD
  • smoking history
  • pregnancy
  • cardiaovascular disease
  • patients with acute respiratory infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 886, Taiwan

Location

MeSH Terms

Conditions

Asthma

Interventions

Foster Home Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Shih-Lung Cheng

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 4, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)