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

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

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: Foster

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 886
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Foster; uncontrolled asthma patients were randomized into Foster treatment group	Drug: Foster; a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation; Other Names: Relvar
ACTIVE_COMPARATOR: Relvar; uncontrolled asthma patients were randomized into Relvar treatment group	Drug: Foster; a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation; Other Names: Relvar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function improvement	FEV1	one year

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Collaborators: Orient Europharma Co., Ltd.
• Investigators: Principal Investigator: Shih-Lung Cheng, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Foster 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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