Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy

• Status: Terminated
• Trial end date: 2020-09-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of the Asthma improvement of Flutiform K-haler after 12 weeks of treatment in patients with moderate to severe uncontrolled* asthma following mid-dose ICS/LABA DPI therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Korea Ltd

Criteria

Inclusion Criteria:

1. Korean asthma patients age ≥ 19 years old

2. Patients who have moderate to severe persistent asthma, as defined by GINA 2018 guideline, with ICS/LABA DPI use history

3. Patients who have uncontrolled asthma in FEV1 up to 60% and Asthma control test score < 20

4. Female subjects of child bearing potential must have a negative urine pregnancy test prior to first dose of study medication and that they must be agree to use adequate contraception during the study period

5. Patients who are able to use the inhaler

6. Patients who is willing to voluntarily sign the study consent form

Exclusion Criteria:

1. Patients who have diagnosed as clinically significant pulmonary diseases

2. Patients who have experienced life-threatening asthma within 12 months prior to screening or respiratory infection within 4 weeks prior to screening, or patients who have experienced any emergency visit or hospitalization due to acute asthma symptoms within 4 weeks prior to screening

3. Current and past smoker: Smoker defined as below

• Current smoker: smoking history within 90 days prior to screening

• Past smoker: smoking amount >10 pack year

4. Patients who currently are pregnant or lactating

5. Patients who are participating or going to participate in any interventional clinical trials

6. QT interval prolongation in ECG result at screening (420msec > male, 440msec > female)

7. Patients with hypersensitive to investigational products or to any component of the drug

8. Patients requiring treatment with any of the prohibited concomitant medications Use of the following medications is prohibited during the study due to drug-to-drug interaction with the study drug

9. Patients who took SPIRIVA within 3 month prior to enrollment

10. Patients who did not show previous DPI drug compliance between 70% ~130%