AsthmaPhase 4RECONFFIRMNCT02491970
Small Airway Function of Fluticasone/Formoterol (Flutiform®) and Fluticasone/Salmeterol
A Phase 4 study testing Fluticasone/Formoterol and Fluticasone/Salmeterol in people with Asthma, run by Mundipharma Korea Ltd.
Trial summary
The purpose of this study is to demonstrate superiority of Fluticasone/Formoterol (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA concomitant treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone/Formoterol and Fluticasone/Salmeterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2015to May 2017
- Phase
- Phase 4
- 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
- Adult (over 19 years) asthma patients
- Patients who have a history of mild-to-moderate-severe, persistent asthma for at least 6 months prior to Screening.
- Patients who were required to demonstrate a FEV1 of ≥ 40 % and ≤ 85% of predicted normal values during screening period following appropriate withholding of asthma medications (if applicable).
- Patients who were required to show reversibility of ≥15% FEV1 after salbutamol inhalation (2 actuations, 100µg per actuation) from the pre- salbutamol value at screening
- Patients who have uncontrolled asthma by Seretide® 250/50 defined as ACT less than 20
- Patients who showed R5-20 more than 0.1 kPa/L/s
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- Blood eosinophil count > 300/µL on screening visit
- Female patients of childbearing potential must have a negative urine pregnancy test at Screening.
- 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 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
- Patients who have diagnosed as clinically significant disease or non- reversible pulmonary disease or patients who currently have active pulmonary disease (eg. COPD, cystic fibrosis, bronchiectasis, active tuberculosis)
- Patients who have diagnosed as laryngitis, chronic sinusitis, infectious rhinitis or allergic rhinitis within 4 weeks prior to screening, or patients who have had any symptoms of acute exacerbation or purulent discharge by the disease above within 2 weeks prior to screening
- Current smoker or past smoker defined as below:
- Current smoker: smoking history within 12 months prior to screening
- Past smoker: smoking amount ≥10 pack year*
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- Pack year (PY) calculation: average amount of smoking per day (pack) x duration of smoking (year)
- Patients who currently are pregnant or lactating
- Patient who had taken systemic corticosteroid within 4 weeks prior to screening
- Patients who had taken omalizumab within 24 weeks prior to screening
- Patients who had taken the following medications within 1 week prior to screening:
- potent CYP3A inhibitors
- β-blockers
- monoamine oxidase inhibitor
- TCA (tricyclic antidepressants)
- quinidine-type anti arrhythmic
- Leukotriene anatagonist
- Astemizole
- Patients who are participating or going to participate in any interventional clinical trials
- QT interval prolongation in ECG result at screening
- Patients with hypersensitive to investigational products or to any component of the drug
- Patients who are judged difficult to participate in this investigation by the investigator
About this study
Official title: A Single-blind, Randomized, Active-controlled, Multi-center and Phase IV Study to Evaluate the Small Airway Parameters of Fluticasone/Formoterol (Flutiform®) Compared to Fluticasone/Salmeterol in Asthma Patients
The purpose of this study is to demonstrate superiority of Fluticasone/Formoterol (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA concomitant treatment.
- Conditions
- Asthma
- Being tested
- Fluticasone/Formoterol, Fluticasone/Salmeterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone/FormoterolDrug
Also called Flutiform
Fluticasone/SalmeterolDrug
Also called Seretide
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone/Formoterol | Experimental | Brand name: Flutiform Dose: 250/10μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation Receives: Drug: Fluticasone/Formoterol |
| Fluticasone/Salmeterol | Active comparator | Brand name: Seretide Dose: 250/50μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation Receives: Drug: Fluticasone/Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy superiority as measured by Impulse Oscillometric System
To compare Fluticasone/Formoterol to Fluticasone/salmeterol, assessing the change in the mean R5-R20 measured by the Impulse Oscillometic System (IOS) in uncontrolled asthma patients
Measured: 12 weeks
Secondary outcomes (1)
Incidence of adverse drug reactions as a measure of safety
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study start31 Aug 2015
- Primary completion6 Apr 2017
- Study completionMay 2017
Why it stopped: Difficulty of patients enrollments
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491970
- Sponsor's protocol ID
- FLT14-KR-401
- Acronym
- RECONFFIRM
- Status last verified
- May 2018
- First submitted
- 15 Jun 2015
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Active-controlled, Multi-center and Phase IV Study to Evaluate the Small Airway Parameters of Fluticasone/Formoterol (Flutiform®) Compared to Fluticasone/Salmeterol in Asthma Patients
- ClinicalTrials.gov ID
- NCT02491970
- Acronym / sponsor ID
- RECONFFIRM / FLT14-KR-401
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of patients enrollments
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Jul 2015 (estimated)
- 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 demonstrate superiority of Fluticasone/Formoterol (Flutiform®) to Fluticasone/salmeterol based on the small airway function by assessing the Impulse Oscillometic System (IOS) in uncontrolled asthma patients requiring ICS/LABA concomitant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone/Formoterol | Experimental | Drug: Fluticasone/FormoterolBrand name: Flutiform Dose: 250/10μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation |
| Fluticasone/Salmeterol | Active comparator | Drug: Fluticasone/SalmeterolBrand name: Seretide Dose: 250/50μg (2 puffs/once, BID) Duration of treatment: 12 weeks Mode of administration: oral inhalation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult (over 19 years) asthma patients
- Patients who have a history of mild-to-moderate-severe, persistent asthma for at least 6 months prior to Screening.
- Patients who were required to demonstrate a FEV1 of ≥ 40 % and ≤ 85% of predicted normal values during screening period following appropriate withholding of asthma medications (if applicable).
- Patients who were required to show reversibility of ≥15% FEV1 after salbutamol inhalation (2 actuations, 100µg per actuation) from the pre- salbutamol value at screening
- Patients who have uncontrolled asthma by Seretide® 250/50 defined as ACT less than 20
Key exclusion criteria (22 listed)
- 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
- Patients who have diagnosed as clinically significant disease or non- reversible pulmonary disease or patients who currently have active pulmonary disease (eg. COPD, cystic fibrosis, bronchiectasis, active tuberculosis)
- Patients who have diagnosed as laryngitis, chronic sinusitis, infectious rhinitis or allergic rhinitis within 4 weeks prior to screening, or patients who have had any symptoms of acute exacerbation or purulent discharge by the disease above within 2 weeks prior to screening
- Current smoker or past smoker defined as below:
- Patients who currently are pregnant or lactating
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 |
|---|---|---|
| Fluticasone/FormoterolAlso: Flutiform | Drug | Fluticasone/Formoterol |
| Fluticasone/SalmeterolAlso: Seretide | Drug | Fluticasone/Salmeterol |
Primary outcome
Efficacy superiority as measured by Impulse Oscillometric System
Time frame: 12 weeks
To compare Fluticasone/Formoterol to Fluticasone/salmeterol, assessing the change in the mean R5-R20 measured by the Impulse Oscillometic System (IOS) in uncontrolled asthma patients
1 secondary outcome
Incidence of adverse drug reactions as a measure of safety
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Difficulty of patients enrollments). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone/Formoterol and Fluticasone/Salmeterol in people with Asthma, run by Mundipharma Korea Ltd.
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 10 inclusion and 22 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 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Difficulty of patients enrollments). 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?
Efficacy superiority as measured by Impulse Oscillometric System (time frame: 12 weeks). 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 16 May 2018.