AsthmaPhase 3SWIFTNCT04124510
Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy
A Phase 3 study testing Brand Name: Flutiform K-haler in people with Asthma, run by Mundipharma Korea Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Brand Name: Flutiform K-haler
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Nov 2019to 14 Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 12-week, Prospective, Interventional, Single-arm, Multi-centre, Phase III Study to Examine the Efficacy and Safety of Flutiform K-haler in Asthma Patients Who Are Not Adequately Controlled by Mid-doseICS/LABA DPI Treatment
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.
Read the 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, dyspnea, and tightness in the chest. An estimated 300 million people worldwide suffer from asthma, and in South Korea, an estimated asthma prevalence rate for adults is approximately 5% [1]. For more effective management of asthma, Global Initiative for Asthma (GINA) guideline[2] and Korean Asthma Management Guideline for Adults [1] suggests that for patients who cannot have asthma symptoms under control with ICS (Inhaled Corticosteroid) alone, concomitant treatment of ICS/LABA is more effective than dose increase of ICS, and therefore recommends ICS combined with Long-acting β2-agonist (LABA) products. Common ICS/LABA products that are available in the Korea market including dry power inhaler (DPI) and pressured metered dose inhaler (pMDI).
It is known that small airway significantly contributes to total airway resistance, so the inflammation of the small airways could lead to the poor asthma control observed since small airways are not directly reached by inhaler's particles [3,4]. Fluticasone/formoterol (Flutiform®) shows a high fine particle fraction (FPF) of about 40% for both the ICS and the LABA components regardless the inhalation flow rate[5]. FPF of Fluticasone/formoterol is significantly higher than other ICS/LABA combinations. It is expected that small particles of fluticason/formoterol could reach to the large/small airways easier than other ICS/LABA combinations even if these ICS/LABAs shows a similar efficacy for asthma treatment. However Asthma patients can struggle to use their pMDI inhalers correctly due to the need to properly co-ordinate the press and inhale, which can worsen their asthma and lead to exacerbations.
Flutiform K-haler is the first breath-actuated inhaled corticosteroid (ICS) long-acting β2-agonist (LABA) combination aerosol inhaler for adults and adolescents. The flutiform k-haler has been designed with patients in mind, requiring only a gentle inhalation to trigger the dose release, with the aim to help patients reduce critical errors and improve long-term outcomes.
Therefore, It is expected that Flutiform K-haler prevents exacerbation and improves symptom of Asthma. Especially it will be beneficial to patients who did not response to existing ICS/LABA DPI in Korea. This study is planned to examine the efficacy and safety of Flutiform K-haler in patients who are not adequately controlled by previous mid-dose ICS/LABA DPI treatment.
- Conditions
- Asthma
- Being tested
- Brand Name: Flutiform K-haler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brand Name: Flutiform K-halerDrug
Also called Flutiform K-haler
Brand Name: Flutiform K-haler Generic name: Fluticasone/formoterol dosage form: oral inhalation
| Study group | Role | What they receive |
|---|---|---|
| Brand Name: Flutiform K-haler | Experimental | Brand Name: Flutiform K-haler Generic name: Fluticasone/formoterol dosage form: oral inhalation Receives: Drug: Brand Name: Flutiform K-haler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 0, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start26 Nov 2019
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Why it stopped: The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwang Ha Yoo, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124510
- Sponsor's protocol ID
- FLT18-KR-301
- Acronym
- SWIFT
- Status last verified
- Jan 2021
- First submitted
- 30 Sep 2019
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 12-week, Prospective, Interventional, Single-arm, Multi-centre, Phase III Study to Examine the Efficacy and Safety of Flutiform K-haler in Asthma Patients Who Are Not Adequately Controlled by Mid-doseICS/LABA DPI Treatment
- ClinicalTrials.gov ID
- NCT04124510
- Acronym / sponsor ID
- SWIFT / FLT18-KR-301
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, dyspnea, and tightness in the chest. An estimated 300 million people worldwide suffer from asthma, and in South Korea, an estimated asthma prevalence rate for adults is approximately 5% [1]. For more effective management of asthma, Global Initiative for Asthma (GINA) guideline[2] and Korean Asthma Management Guideline for Adults [1] suggests that for patients who cannot have asthma symptoms under control with ICS (Inhaled Corticosteroid) alone, concomitant treatment of ICS/LABA is more effective than dose increase of ICS, and therefore recommends ICS combined with Long-acting β2-agonist (LABA) products. Common ICS/LABA products that are available in the Korea market including dry power inhaler (DPI) and pressured metered dose inhaler (pMDI).
It is known that small airway significantly contributes to total airway resistance, so the inflammation of the small airways could lead to the poor asthma control observed since small airways are not directly reached by inhaler's particles [3,4]. Fluticasone/formoterol (Flutiform®) shows a high fine particle fraction (FPF) of about 40% for both the ICS and the LABA components regardless the inhalation flow rate[5]. FPF of Fluticasone/formoterol is significantly higher than other ICS/LABA combinations. It is expected that small particles of fluticason/formoterol could reach to the large/small airways easier than other ICS/LABA combinations even if these ICS/LABAs shows a similar efficacy for asthma treatment. However Asthma patients can struggle to use their pMDI inhalers correctly due to the need to properly co-ordinate the press and inhale, which can worsen their asthma and lead to exacerbations.
Flutiform K-haler is the first breath-actuated inhaled corticosteroid (ICS) long-acting β2-agonist (LABA) combination aerosol inhaler for adults and adolescents. The flutiform k-haler has been designed with patients in mind, requiring only a gentle inhalation to trigger the dose release, with the aim to help patients reduce critical errors and improve long-term outcomes.
Therefore, It is expected that Flutiform K-haler prevents exacerbation and improves symptom of Asthma. Especially it will be beneficial to patients who did not response to existing ICS/LABA DPI in Korea. This study is planned to examine the efficacy and safety of Flutiform K-haler in patients who are not adequately controlled by previous mid-dose ICS/LABA DPI treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brand Name: Flutiform K-haler | Experimental | Drug: Brand Name: Flutiform K-halerBrand Name: Flutiform K-haler Generic name: Fluticasone/formoterol dosage form: oral inhalation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
- Patients who currently are pregnant or lactating
- Patients who are participating or going to participate in any interventional clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brand Name: Flutiform K-halerAlso: Flutiform K-halerBrand Name: Flutiform K-haler Generic name: Fluticasone/formoterol dosage form: oral inhalation | Drug | Brand Name: Flutiform K-haler |
Primary outcome
The primary endpoint of the study is the change in Asthma control test from baseline to Week 12 on treatment
Time frame: Week 0, Week 12
change in Asthma control test from baseline to Week 12 on treatment
Results and safety
The study was stopped early (reason given: The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwang Ha Yoo principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brand Name: Flutiform K-haler in people with Asthma, run by Mundipharma Korea Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the change in Asthma control test from baseline to Week 12 on treatment (time frame: Week 0, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.