Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma
Brief Summary: A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder inhaler (DPI) is being developed by GlaxoSmithKline (GSK) 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 is a phase III, multi-center, active-controlled, double-blind, parallel-group study to compare the efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization, Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol, 250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice a day. At Visit 2 (Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI (100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks. Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and 8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be conducted approximately 7 days after the end of treatment period or, if applicable, after the early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. Approximately 2250 subjects will be randomized, with approximately 375 subjects randomized to each of the 6 double-blind treatment arms to ensure approximately 337 evaluable subjects per treatment arm. DISKUS and ELLIPTA are registered trademarks of GSK groups of companies.


Options:
A: Arm Label: FF/UMEC/VI (100/31.25/25) mcg closed triple therapy; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI (100/31.25/25) mcg, Drug: FF/VI (100/25) mcg, Drug: Fluticasone/salmeterol (FSC), Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: DISKUS DPI, Device: METERED-DOSE INHALER (MDI) | Arm Label: FF/UMEC/VI (100/62.5/25) mcg closed triple therapy; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI (100/62.5/25) mcg, Drug: FF/VI (100/25) mcg, Drug: Fluticasone/salmeterol (FSC), Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: DISKUS DPI, Device: METERED-DOSE INHALER (MDI) | Arm Label: FF/UMEC/VI (200/31.25/25) mcg closed triple therapy; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI (200/31.25/25) mcg, Drug: FF/VI (100/25) mcg, Drug: Fluticasone/salmeterol (FSC), Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: DISKUS DPI, Device: METERED-DOSE INHALER (MDI) | Arm Label: FF/UMEC/VI (200/62.5/25) mcg closed triple therapy; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI (200/62.5/25) mcg, Drug: FF/VI (100/25) mcg, Drug: Fluticasone/salmeterol (FSC), Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: DISKUS DPI, Device: METERED-DOSE INHALER (MDI) | Arm Label: FF/VI (100/25) mcg dual combination therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: FF/VI (100/25) mcg, Drug: Fluticasone/salmeterol (FSC), Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: DISKUS DPI, Device: METERED-DOSE INHALER (MDI) | Arm Label: FF/VI (200/25) mcg dual combination therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: FF/VI (100/25) mcg, Drug: FF/VI (200/25) mcg, Drug: Fluticasone/salmeterol (FSC), Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: DISKUS DPI, Device: METERED-DOSE INHALER (MDI) | Intervention Type: DRUG; Name: FF/UMEC/VI (100/31.25/25) mcg; Assigned to Arm(s): FF/UMEC/VI (100/31.25/25) mcg closed triple therapy | Intervention Type: DRUG; Name: FF/UMEC/VI (100/62.5/25) mcg; Assigned to Arm(s): FF/UMEC/VI (100/62.5/25) mcg closed triple therapy | Intervention Type: DRUG; Name: FF/UMEC/VI (200/31.25/25) mcg; Assigned to Arm(s): FF/UMEC/VI (200/31.25/25) mcg closed triple therapy | Intervention Type: DRUG; Name: FF/UMEC/VI (200/62.5/25) mcg; Assigned to Arm(s): FF/UMEC/VI (200/62.5/25) mcg closed triple therapy | Intervention Type: DRUG; Name: FF/VI (100/25) mcg; Assigned to Arm(s): FF/UMEC/VI (100/31.25/25) mcg closed triple therapy, FF/UMEC/VI (100/62.5/25) mcg closed triple therapy, FF/UMEC/VI (200/31.25/25) mcg closed triple therapy, FF/UMEC/VI (200/62.5/25) mcg closed triple therapy, FF/VI (100/25) mcg dual combination therapy, FF/VI (200/25) mcg dual combination therapy | Intervention Type: DRUG; Name: FF/VI (200/25) mcg; Assigned to Arm(s): FF/VI (200/25) mcg dual combination therapy | Intervention Type: DRUG; Name: Fluticasone/salmeterol (FSC); Assigned to Arm(s): FF/UMEC/VI (100/31.25/25) mcg closed triple therapy, FF/UMEC/VI (100/62.5/25) mcg closed triple therapy, FF/UMEC/VI (200/31.25/25) mcg closed triple therapy, FF/UMEC/VI (200/62.5/25) mcg closed triple therapy, FF/VI (100/25) mcg dual combination therapy, FF/VI (200/25) mcg dual combination therapy | Intervention Type: DRUG; Name: Albuterol/salbutamol; Assigned to Arm(s): FF/UMEC/VI (100/31.25/25) mcg closed triple therapy, FF/UMEC/VI (100/62.5/25) mcg closed triple therapy, FF/UMEC/VI (200/31.25/25) mcg closed triple therapy, FF/UMEC/VI (200/62.5/25) mcg closed triple therapy, FF/VI (100/25) mcg dual combination therapy, FF/VI (200/25) mcg dual combination therapy | Intervention Type: DEVICE; Name: ELLIPTA DPI; Assigned to Arm(s): FF/UMEC/VI (100/31.25/25) mcg closed triple therapy, FF/UMEC/VI (100/62.5/25) mcg closed triple therapy, FF/UMEC/VI (200/31.25/25) mcg closed triple therapy, FF/UMEC/VI (200/62.5/25) mcg closed triple therapy, FF/VI (100/25) mcg dual combination therapy, FF/VI (200/25) mcg dual combination therapy | Intervention Type: DEVICE; Name: DISKUS DPI; Assigned to Arm(s): FF/UMEC/VI (100/31.25/25) mcg closed triple therapy, FF/UMEC/VI (100/62.5/25) mcg closed triple therapy, FF/UMEC/VI (200/31.25/25) mcg closed triple therapy, FF/UMEC/VI (200/62.5/25) mcg closed triple therapy, FF/VI (100/25) mcg dual combination therapy, FF/VI (200/25) mcg dual combination therapy | Intervention Type: DEVICE; Name: METERED-DOSE INHALER (MDI); Assigned to Arm(s): FF/UMEC/VI (100/31.25/25) mcg closed triple therapy, FF/UMEC/VI (100/62.5/25) mcg closed triple therapy, FF/UMEC/VI (200/31.25/25) mcg closed triple therapy, FF/UMEC/VI (200/62.5/25) mcg closed triple therapy, FF/VI (100/25) mcg dual combination therapy, FF/VI (200/25) mcg dual combination therapy
B: Arm Label: QVM149 150/50/160 µg o.d.; Type: EXPERIMENTAL; Interventions: Drug: QVM149 150/50/160 | Arm Label: QVM149 150/50/80 µg o.d.; Type: EXPERIMENTAL; Interventions: Drug: QVM149 150/50/80 | Arm Label: QMF149 150/320 µg o.d.; Type: ACTIVE_COMPARATOR; Interventions: Drug: QMF149 150/320 | Arm Label: QMF149 150/160 µg o.d.; Type: ACTIVE_COMPARATOR; Interventions: Drug: QMF149 150/160 | Arm Label: Salmeterol/fluticasone 50/500 μg b.i.d.; Type: ACTIVE_COMPARATOR; Interventions: Drug: salmeterol/fluticasone | Intervention Type: DRUG; Name: QVM149 150/50/160; Assigned to Arm(s): QVM149 150/50/160 µg o.d. | Intervention Type: DRUG; Name: QVM149 150/50/80; Assigned to Arm(s): QVM149 150/50/80 µg o.d. | Intervention Type: DRUG; Name: QMF149 150/320; Assigned to Arm(s): QMF149 150/320 µg o.d. | Intervention Type: DRUG; Name: QMF149 150/160; Assigned to Arm(s): QMF149 150/160 µg o.d. | Intervention Type: DRUG; Name: salmeterol/fluticasone; Assigned to Arm(s): Salmeterol/fluticasone 50/500 μg b.i.d.
C: Arm Label: tiotropium low dose; Type: EXPERIMENTAL; Interventions: Drug: Placebo, Drug: tiotropium Respimat® low dose | Arm Label: tiotropium high dose; Type: EXPERIMENTAL; Interventions: Drug: Placebo, Drug: tiotropium Respimat® high dose | Arm Label: 50 mcg salmeterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: 50 mcg salmeterol HFA MDI, Drug: Placebo | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: tiotropium Respimat® low dose; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): tiotropium high dose | Intervention Type: DRUG; Name: tiotropium Respimat® high dose; Assigned to Arm(s): tiotropium high dose | Intervention Type: DRUG; Name: 50 mcg salmeterol HFA MDI; Assigned to Arm(s): 50 mcg salmeterol | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 50 mcg salmeterol
D: Arm Label: tiotropium 5 mcg; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 5 mcg | Arm Label: tiotropium 2.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 2.5 mcg | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: tiotropium 2.5 mcg; Assigned to Arm(s): tiotropium 2.5 mcg | Intervention Type: DRUG; Name: tiotropium 5 mcg; Assigned to Arm(s): tiotropium 5 mcg

Answer: A