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Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
one-way education
two-way education
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

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

Inclusion Criteria:

  1. Adult at the age of 19 or older.
  2. Patient with partially controlled asthma (Asthma Control Test score 16~24)
  3. Written informed consent to study participation.

Exclusion Criteria:

  1. History of hypersensitivity reactions to the investigational product (Fluterol®) or any of its component.
  2. Cardiac tachyarrhythmia.
  3. contreated respiratory fungal, bacterial, or tuberculous infection.
  4. Moderate to severe bronchiectasis
  5. Planned use of the investigational product (Fluterol®) as primary treatment for patients with status asthmaticus, patients with an asthmatic crisis*, or patients with chronic obstructive pulmonary disease requiring intensive treatment.

    • Asthmatic crisis: acute exacerbation of asthma meeting at least one of the followings.
    • Asthma related emergency room visit or hospitalization within 2 weeks prior to screening.
    • Administration of systemic steroids within 2 weeks prior to screening.
    • Inhalation of rescue medication at least 10 times/day for the treatment of acute exacerbation of asthmatic symptoms within 2 weeks prior to screening.
  6. Administration of systemic steroids within 2 weeks prior to screening.
  7. Hypersensitivity reactions to lactose and milk.
  8. Pregnant and lactating women or women who are planning to be pregnant or who are unwilling to use appropriate methods of contraception during the study.
  9. Previous use of the investigational product (Fluterol®) or a similar inhaler (Onbrez, Spiriva) at least once.
  10. Participation in another clinical study for drugs or medical devices to receive the investigational product or undergo a procedure using the investigational device within 4 weeks prior to participation in this study.
  11. Individual considered by the he investigator to be inappropriate for study participation due to other reasons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group (one-way education)

    Control group(two-way education)

    Arm Description

    Experimental group (one-way education) Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) video based education

    Control group(two-way education) Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) direct education

    Outcomes

    Primary Outcome Measures

    Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
    method of assessment:Forced expiratory volume

    Secondary Outcome Measures

    percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.
    method of assessment:Forced expiratory volume
    Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.
    method of assessment: Check list
    Change in inhaler technique score at Weeks 4 and 12 from baseline in each group
    method of assessment: Check list
    Number of critical errors at Weeks 4 and 12 in each group.
    method of assessment: Check list
    Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.
    method of assessment: Check list
    Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).
    method of assessment: Check list
    Adherence rate (%) at Weeks 4 and 12 in each group.
    method of assessment: drug administration calculation
    Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.
    occur frequency of adverse events and incidence rate of acute in each group, vital signs: blood pressure and pulse

    Full Information

    First Posted
    March 31, 2017
    Last Updated
    February 21, 2018
    Sponsor
    Hanmi Pharmaceutical Company Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03110874
    Brief Title
    Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control
    Official Title
    A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients With Partly Controlled Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 8, 2015 (Actual)
    Primary Completion Date
    September 1, 2016 (Actual)
    Study Completion Date
    May 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hanmi Pharmaceutical Company Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A multi-center, randomized, open, non-inferiority, Phase 4 study
    Detailed Description
    A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients with Partly Controlled Asthma

    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
    Care Provider
    Allocation
    Randomized
    Enrollment
    184 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group (one-way education)
    Arm Type
    Experimental
    Arm Description
    Experimental group (one-way education) Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) video based education
    Arm Title
    Control group(two-way education)
    Arm Type
    Active Comparator
    Arm Description
    Control group(two-way education) Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) direct education
    Intervention Type
    Drug
    Intervention Name(s)
    one-way education
    Other Intervention Name(s)
    video based education
    Intervention Description
    'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'
    Intervention Type
    Drug
    Intervention Name(s)
    two-way education
    Other Intervention Name(s)
    direct education
    Intervention Description
    'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'
    Primary Outcome Measure Information:
    Title
    Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
    Description
    method of assessment:Forced expiratory volume
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.
    Description
    method of assessment:Forced expiratory volume
    Time Frame
    Week 4
    Title
    Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.
    Description
    method of assessment: Check list
    Time Frame
    Weeks 4 and 12
    Title
    Change in inhaler technique score at Weeks 4 and 12 from baseline in each group
    Description
    method of assessment: Check list
    Time Frame
    Weeks 4 and 12
    Title
    Number of critical errors at Weeks 4 and 12 in each group.
    Description
    method of assessment: Check list
    Time Frame
    Weeks 4 and 12
    Title
    Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.
    Description
    method of assessment: Check list
    Time Frame
    Weeks 4 and 12
    Title
    Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).
    Description
    method of assessment: Check list
    Time Frame
    Weeks 4 and 12
    Title
    Adherence rate (%) at Weeks 4 and 12 in each group.
    Description
    method of assessment: drug administration calculation
    Time Frame
    Weeks 4 and 12
    Title
    Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.
    Description
    occur frequency of adverse events and incidence rate of acute in each group, vital signs: blood pressure and pulse
    Time Frame
    baseline(day1),weeks 4 and weeks12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult at the age of 19 or older. Patient with partially controlled asthma (Asthma Control Test score 16~24) Written informed consent to study participation. Exclusion Criteria: History of hypersensitivity reactions to the investigational product (Fluterol®) or any of its component. Cardiac tachyarrhythmia. contreated respiratory fungal, bacterial, or tuberculous infection. Moderate to severe bronchiectasis Planned use of the investigational product (Fluterol®) as primary treatment for patients with status asthmaticus, patients with an asthmatic crisis*, or patients with chronic obstructive pulmonary disease requiring intensive treatment. Asthmatic crisis: acute exacerbation of asthma meeting at least one of the followings. Asthma related emergency room visit or hospitalization within 2 weeks prior to screening. Administration of systemic steroids within 2 weeks prior to screening. Inhalation of rescue medication at least 10 times/day for the treatment of acute exacerbation of asthmatic symptoms within 2 weeks prior to screening. Administration of systemic steroids within 2 weeks prior to screening. Hypersensitivity reactions to lactose and milk. Pregnant and lactating women or women who are planning to be pregnant or who are unwilling to use appropriate methods of contraception during the study. Previous use of the investigational product (Fluterol®) or a similar inhaler (Onbrez, Spiriva) at least once. Participation in another clinical study for drugs or medical devices to receive the investigational product or undergo a procedure using the investigational device within 4 weeks prior to participation in this study. Individual considered by the he investigator to be inappropriate for study participation due to other reasons.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Byoung Whui Choi
    Organizational Affiliation
    Chung-Ang University Hosptial, Chung-Ang University College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control

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