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AsthmaPhase 3NCT03184987

A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma

A Phase 3 study testing FF/UMEC/VI 100/62.5/25 mcg, FF/UMEC/VI 200/62.5/25 mcg and Salbutamol in people with Asthma, run by GlaxoSmithKline at 13 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite availability of treatments and published guidelines, subjects may have asthma that is inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic Antagonist (ICS/LAMA/LABA) combination… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
FF/UMEC/VI 100/62.5/25 mcg, FF/UMEC/VI 200/62.5/25 mcg and Salbutamol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
13 sitesJapan
Study dates
22 Jun 2017to 25 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Asthma maintenance therapy: No changes in asthma maintenance therapy (excluding salbutamol inhalation aerosol provided at Visit 1) and control status during the run-in period. Asthma Control Questionnaire (ACQ-6 at screening and ACQ-7 at the end of the run-in period) will be used for the assessment of control status of asthma, i.e., 0.75 points shows controlled and >0.75 shows not well controlled.
  • Concurrent conditions/medical history: Liver function test at Visit1
  • ALT <2 x upper limit of normal (ULN)
  • ALP less than or equal to 1.5 x ULN
  • Bilirubin less than or equal to 1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

Who cannot join

  • Respiratory Infection: Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
  • Severe asthma exacerbation: Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
  • Laboratory test abnormalities: Evidence of clinically significant abnormal laboratory tests during screening or the run-in period which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality.
  • There is no restriction on diet in this study.
  • Use of tobacco products will not be allowed from screening until after the final follow-up visit. Caffeine and alcohol is allowed ad libitum.
  • There is no restriction on activity in this study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Japan13 sites

  • GSK Investigational Site

    Gifu, 509-6134

  • GSK Investigational Site

    Gunma, 372-0831

  • GSK Investigational Site

    Gunma, 373-0807

  • GSK Investigational Site

    Hiroshima, 732-0052

  • GSK Investigational Site

    Kagawa, 762-8550

  • GSK Investigational Site

    Kanagawa, 236-0004

  • GSK Investigational Site

    Kyoto, 607-8062

  • GSK Investigational Site

    Okinawa, 901-2121

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 134-0083

  • GSK Investigational Site

    Tokyo, 157-0066

  • GSK Investigational Site

    Tokyo, 169-0073

  • GSK Investigational Site

    Toyama, 937-0042

Other trials in Japan

About this study

Official title: A Phase III, 52-week, Open-label Study to Evaluate Long-term Safety of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Patients With Asthma

Despite availability of treatments and published guidelines, subjects may have asthma that is inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate [FF/UMEC/VI]) in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. This study has 3 study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period. Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2 subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25 micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in accordance with the control status of the subject assessed by Asthma Control Questionnaire (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for approximately 1 week. Subjects will be provided with salbutamol as a rescue medication throughout the study.

Conditions
Asthma
Being tested
FF/UMEC/VI 100/62.5/25 mcg, FF/UMEC/VI 200/62.5/25 mcg, Salbutamol, ACQ-7
Keywords
fluticasone furoate, fixed dose combination, Japanese subjects, vilanterol, asthma, umeclidinium bromide, closed triple therapy
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FF/UMEC/VI 100/62.5/25 mcgDrug

    Subjects will self-administer the study treatment via the ELLIPTA device. The ELLIPTA holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister. ELLIPTA is a registered trademark of GSK groups of companies.

  • FF/UMEC/VI 200/62.5/25 mcgDrug

    Subjects will self-administer the study treatment via the ELLIPTA device. The ELLIPTA holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister. ELLIPTA is a registered trademark of GSK groups of companies.

  • SalbutamolDrug

    Salbutamol is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.

  • ACQ-7Other

    ACQ-7 will be used for the assessment of control status of asthma.

Study groups in NCT03184987
Study groupRoleWhat they receive
FF/UMEC/VI 100/62.5/25 mcg closed triple therapyExperimentalSubjects will receive FF/UMEC/VI 100/62.5/25 mcg inhalation powder via ELLIPTA, once daily, 1 puff/time, in the morning. Subjects may receive salbutamol as a rescue medication when needed throughout the run-in and treatment period.
Receives: Drug: FF/UMEC/VI 100/62.5/25 mcg; Drug: Salbutamol; Other: ACQ-7
FF/UMEC/VI 200/62.5/25 mcg closed triple therapyExperimentalSubjects will receive FF/UMEC/VI 200/62.5/25 mcg inhalation powder via ELLIPTA, once daily, 1 puff/time, in the morning. Subjects may receive salbutamol as a rescue medication when needed throughout the run-in and treatment period.
Receives: Drug: FF/UMEC/VI 200/62.5/25 mcg; Drug: Salbutamol; Other: ACQ-7

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) is any untoward medical occurrence in clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect, other important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcome mentioned before. Intent-To-Treat (ITT) Population comprised of all participants who received at least one dose of study treatment in the treatment period.

    Measured: Up to Week 52

Secondary outcomes (19)

  1. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 4, 12, 24, 36 and 52

  2. Change From Baseline in Pulse Rate

    Pulse rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 4, 12, 24, 36 and 52

  3. Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)

    Single 12-lead electrocardiograms (ECG) were obtained using an automated ECG machine that measured PR Interval and QTcF Interval. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 4, 24 and 52

  4. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  5. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

    Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  6. Change From Baseline in Hematology Parameter: Erythrocytes

    Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  7. Change From Baseline in Hematology Parameter: Hematocrit

    Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  8. Change From Baseline in Hematology Parameter: Hemoglobin

    Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  9. Change From Baseline in Hematology Parameter: Platelet Count

    Blood samples were collected to analyze the hematology parameter: platelet count. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  10. Change From Baseline in Hematology Parameter: Basophils/Leukocytes

    Blood samples were collected to analyze the hematology parameter: Basophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  11. Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes

    Blood samples were collected to analyze the hematology parameter: Eosinophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  12. Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes

    Blood samples were collected to analyze the hematology parameter: Lymphocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  13. Change From Baseline in Hematology Parameter: Monocytes/Leukocytes

    Blood samples were collected to analyze the hematology parameter: Monocytes/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  14. Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes

    Blood samples were collected to analyze the hematology parameter: Neutrophils/Leukocytes. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  15. Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase

    Blood samples were collected to analyze the chemistry parameters: alanine aminotransferase, alkaline phosphatase and aspartate aminotransferase. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  16. Change From Baseline in Chemistry Parameters: Albumin, Protein

    Blood samples were collected to analyze the chemistry parameters: albumin and protein. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  17. Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin

    Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  18. Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea

    Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and urea. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as relevant visit value minus Baseline value.

    Measured: Baseline (Day 1), Weeks 12, 24 and 52

  19. Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline

    Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as Trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1) and up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start22 Jun 2017
  3. Primary completion25 Jun 2019
  4. Study completion25 Jun 2019

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03184987
Sponsor's protocol ID
207236
Status last verified
Mar 2020
First submitted
9 Jun 2017
Last updated
29 May 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FF/UMEC/VI 100/62.5/25 mcg, FF/UMEC/VI 200/62.5/25 mcg and Salbutamol in people with Asthma, run by GlaxoSmithKline at 13 sites in Japan.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 29 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03184987.

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 29 May 2020.

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