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

Study Overview
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Brief Summary
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A multi-center, randomized, open, non-inferiority, Phase 4 study

Detailed Description
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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

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: one-way education
* Drug: two-way education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (one-way education)<br>Experimental group (one-way education) Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) video based education | Drug: one-way education<br>* 'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'<br>* Other names: video based education;|
| Active Comparator: Control group(two-way education)<br>Control group(two-way education) Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) direct education | Drug: two-way education<br>* 'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'<br>* Other names: direct education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group. | method of assessment:Forced expiratory volume | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group. | method of assessment:Forced expiratory volume | Week 4 | 
| Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group. | method of assessment: Check list | Weeks 4 and 12 | 
| Change in inhaler technique score at Weeks 4 and 12 from baseline in each group | method of assessment: Check list | Weeks 4 and 12 | 
| Number of critical errors at Weeks 4 and 12 in each group. | method of assessment: Check list | Weeks 4 and 12 | 
| Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group. | method of assessment: Check list | Weeks 4 and 12 | 
| Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score). | method of assessment: Check list | Weeks 4 and 12 | 
| Adherence rate (%) at Weeks 4 and 12 in each group. | method of assessment: drug administration calculation | Weeks 4 and 12 | 
| 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 | baseline(day1),weeks 4 and weeks12 |