Status:
TERMINATED
Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy
Lead Sponsor:
Mundipharma Korea Ltd
Conditions:
Asthma
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Asthma is a chronic inflammatory allergic disease of airway involving many cells and various media. Airway inflammation causes various symptoms of airway hypersensitivity, including repeated wheezing,...
Eligibility Criteria
Inclusion
- Korean asthma patients age ≥ 19 years old
- Patients who have moderate to severe persistent asthma, as defined by GINA 2018 guideline, with ICS/LABA DPI use history
- Patients who have uncontrolled asthma in FEV1 up to 60% and Asthma control test score \< 20
- 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
- Patients who are able to use the inhaler
- Patients who is willing to voluntarily sign the study consent form
Exclusion
- Patients who have diagnosed as clinically significant pulmonary diseases
- 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
- 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
- Patients who currently are pregnant or lactating
- Patients who are participating or going to participate in any interventional clinical trials
- QT interval prolongation in ECG result at screening (420msec \> male, 440msec \> female)
- Patients with hypersensitive to investigational products or to any component of the drug
- 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
- Patients who took SPIRIVA within 3 month prior to enrollment
- Patients who did not show previous DPI drug compliance between 70% \~130%
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04124510
Start Date
November 26 2019
End Date
September 14 2020
Last Update
January 25 2021
Active Locations (1)
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1
Konkuk University Medical Center
Seoul, South Korea, 05030