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Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Seretide
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, SMART, fixed dose

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • asthma not well control

Exclusion Criteria:

  • COPD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Symbicort

    Seretide

    Arm Description

    We will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period. Intervention drug: Seretide fixed doses therapy

    In non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year

    Outcomes

    Primary Outcome Measures

    the percentage of asthma total and well control
    F/U clinical asthma control status and percentage of Acute exacerbation

    Secondary Outcome Measures

    percentage of asthma acute exacerbation

    Full Information

    First Posted
    July 19, 2012
    Last Updated
    July 23, 2012
    Sponsor
    Far Eastern Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01647646
    Brief Title
    Real Life Effectiveness in Patients With Not Optimally Controlled Asthma
    Official Title
    Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Far Eastern Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.
    Detailed Description
    All not-well controlled asthma patients would include the study. We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses We will evaluate the efficacy/safety for these not-well controlled patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    asthma, SMART, fixed dose

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Symbicort
    Arm Type
    Active Comparator
    Arm Description
    We will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period. Intervention drug: Seretide fixed doses therapy
    Arm Title
    Seretide
    Arm Type
    Experimental
    Arm Description
    In non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year
    Intervention Type
    Drug
    Intervention Name(s)
    Seretide
    Other Intervention Name(s)
    Symbicort compared with Seretide
    Intervention Description
    Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety
    Primary Outcome Measure Information:
    Title
    the percentage of asthma total and well control
    Description
    F/U clinical asthma control status and percentage of Acute exacerbation
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    percentage of asthma acute exacerbation
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: asthma not well control Exclusion Criteria: COPD

    12. IPD Sharing Statement

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    Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

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