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

• Status: Completed
• Trial end date: 2017-05-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Fluticasone; Salmeterol Xinafoate

Criteria

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.