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

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

A multi-center, randomized, open, non-inferiority, Phase 4 study

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: one-way education; Drug: two-way education

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Byoung Whui Choi, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 10, 2017

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: HM-FLU-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED