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

NCT04124510 | Terminated Phase 3

• 1 other identifier: FLT18-KR-301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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-dose ICS/LABA DPI therapy.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is the change in Asthma control test from baseline to Week 12 on treatment

  change in Asthma control test from baseline to Week 12 on treatment

  Week 0, Week 12

Study Arms (1)

Brand Name: Flutiform K-haler

EXPERIMENTAL

Brand Name: Flutiform K-haler Generic name: Fluticasone/formoterol dosage form: oral inhalation

Drug: Brand Name: Flutiform K-haler

Interventions

Brand Name: Flutiform K-haler DRUG

Brand Name: Flutiform K-haler Generic name: Fluticasone/formoterol dosage form: oral inhalation

Also known as: Flutiform K-haler

Brand Name: Flutiform K-haler

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kwang Ha Yoo

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 11, 2019
• Study Start: November 26, 2019
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

KR (1)