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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110874
• Other study ID #: HM-FLU-401
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2017
• Last updated: February 21, 2018
• Start date: October 8, 2015
• Est. completion date: May 10, 2017

Study information

• Verified date: February 2018
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 10, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• one-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 µg, salmeterol xinafoate 72.5 µg) : one-way education'
• two-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 µg, salmeterol xinafoate 72.5 µg) : two-way education'

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.	method of assessment: Check list	Weeks 4 and 12
Secondary	Change in inhaler technique score at Weeks 4 and 12 from baseline in each group	method of assessment: Check list	Weeks 4 and 12
Secondary	Number of critical errors at Weeks 4 and 12 in each group.	method of assessment: Check list	Weeks 4 and 12
Secondary	Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.	method of assessment: Check list	Weeks 4 and 12
Secondary	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
Secondary	Adherence rate (%) at Weeks 4 and 12 in each group.	method of assessment: drug administration calculation	Weeks 4 and 12
Secondary	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