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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04185129
• Other study ID #: Foster 001
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2019
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	Orient Europharma Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function improvement	FEV1	one year