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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Study Overview
Brief 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 (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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
FF/UMEC/VI 100/62.5/25 mcg closed triple therapy
Subjects 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.
Intervention: FF/UMEC/VI 100/62.5/25 mcg (Drug)
FF/UMEC/VI 100/62.5/25 mcg closed triple therapy
Subjects 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.
Intervention: Salbutamol (Drug)
FF/UMEC/VI 100/62.5/25 mcg closed triple therapy
Subjects 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.
Intervention: ACQ-7 (Other)
FF/UMEC/VI 200/62.5/25 mcg closed triple therapy
Subjects 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.
Intervention: FF/UMEC/VI 200/62.5/25 mcg (Drug)
FF/UMEC/VI 200/62.5/25 mcg closed triple therapy
Subjects 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.
Intervention: Salbutamol (Drug)
FF/UMEC/VI 200/62.5/25 mcg closed triple therapy
Subjects 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.
Intervention: ACQ-7 (Other)
Outcomes
Primary Outcomes
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 52
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.
Secondary Outcomes
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline (Day 1), Weeks 4, 12, 24, 36 and 52)
- Change From Baseline in Pulse Rate(Baseline (Day 1), Weeks 4, 12, 24, 36 and 52)
- Change From Baseline in PR Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)(Baseline (Day 1), Weeks 4, 24 and 52)
- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Hemoglobin(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Platelet Count(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Basophils/Leukocytes(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Monocytes/Leukocytes(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Chemistry Parameters: Albumin, Protein(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin(Baseline (Day 1), Weeks 12, 24 and 52)
- Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea(Baseline (Day 1), Weeks 12, 24 and 52)
- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline(Baseline (Day 1) and up to Week 52)