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
About this trial
This is an interventional treatment trial for Asthma
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.
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
NCT ID
NCT03110874
First Posted
March 31, 2017
Last Updated
February 21, 2018
Sponsor
Hanmi Pharmaceutical Company Limited
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
We'll reach out to this number within 24 hrs