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Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Foster
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Foster

Relvar

Arm Description

uncontrolled asthma patients were randomized into Foster treatment group

uncontrolled asthma patients were randomized into Relvar treatment group

Outcomes

Primary Outcome Measures

Lung function improvement
FEV1

Secondary Outcome Measures

Full Information

First Posted
November 28, 2019
Last Updated
December 3, 2019
Sponsor
Far Eastern Memorial Hospital
Collaborators
Orient Europharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04185129
Brief Title
Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications
Official Title
Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital
Collaborators
Orient Europharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized study to compare asthma patients using Foster or Relvar.
Detailed Description
The Global Asthma Association (GAA) and the World Allergy Organization (WAO) recently issued statements stating that the small airway is caused by asthma and chronic obstructive pulmonary disease (COPD). Both pathogenesis and treatment play an important role. The small airway is an airway with diameter less than 2 mm and is one of the main sites where airflow obstruction occurs. Small particles (<2 μm) and large particles are more likely to deposit in the distal airways, and have shown to have better effects on asthma and pulmonary obstruction. At the same time, real-life research has also shown that extra-fine particles provide better asthma control than large particles, and can better improve quality of life.The aim of the study is to compare the efficacy of asthma inhalers between extra-fine particles and non-extra-fine particles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foster
Arm Type
Experimental
Arm Description
uncontrolled asthma patients were randomized into Foster treatment group
Arm Title
Relvar
Arm Type
Active Comparator
Arm Description
uncontrolled asthma patients were randomized into Relvar treatment group
Intervention Type
Drug
Intervention Name(s)
Foster
Other Intervention Name(s)
Relvar
Intervention Description
a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation
Primary Outcome Measure Information:
Title
Lung function improvement
Description
FEV1
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients diagnosis with asthma with treatment naive asthma patients with poor controlled status Exclusion Criteria: COPD smoking history pregnancy cardiaovascular disease patients with acute respiratory infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Lung Cheng
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications

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