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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185129
Recruitment Status : Enrolling by invitation
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
Shih-Lung Cheng, Far Eastern Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Foster Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Efficacy in Patients With Asthma Using Foster MDI and Relvar Medications
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: Relvar




Primary Outcome Measures :
  1. Lung function improvement [ Time Frame: one year ]
    FEV1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185129


Locations
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Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, 886
Sponsors and Collaborators
Far Eastern Memorial Hospital
Orient Europharma Co., Ltd.
Investigators
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Principal Investigator: Shih-Lung Cheng Far Eastern Memorial Hospital

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Responsible Party: Shih-Lung Cheng, MD. PhD, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT04185129    
Other Study ID Numbers: Foster 001
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases