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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: one-way education; Drug: two-way education

• Registration Number: NCT03110874
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2015-10-08
• Primary Completion: 2016-09-01
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Completion: 2017-05-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (one-way education)	one-way education	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)	two-way education	Control group(two-way education) * Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) * direct education

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.	Week 4	method of assessment:Forced expiratory volume
Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.	Weeks 4 and 12	method of assessment: Check list
Change in inhaler technique score at Weeks 4 and 12 from baseline in each group	Weeks 4 and 12	method of assessment: Check list
Number of critical errors at Weeks 4 and 12 in each group.	Weeks 4 and 12	method of assessment: Check list
Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.	Weeks 4 and 12	method of assessment: Check list
Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).	Weeks 4 and 12	method of assessment: Check list
Adherence rate (%) at Weeks 4 and 12 in each group.	Weeks 4 and 12	method of assessment: drug administration calculation
Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.	baseline(day1),weeks 4 and weeks12	occur frequency of adverse events and incidence rate of acute in each group, vital signs: blood pressure and pulse