Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 200/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) ALONE OR ON TOP OF OPEN-LABEL TIOTROPIUM 2.5 µg RESPIMAT® IN PATIENTS WITH ASTHMA UNCONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG-ACTING ß2-AGONISTS
Brief Summary: The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993 200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.


Options:
A: Arm Label: CHF 5993 200/6/12.5 µg; Type: EXPERIMENTAL; Interventions: Drug: CHF 5993 200/6/12.5 µg | Arm Label: CHF 1535 200/6 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: CHF 1535 200/6 µg | Arm Label: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg | Intervention Type: DRUG; Name: CHF 5993 200/6/12.5 µg; Assigned to Arm(s): CHF 5993 200/6/12.5 µg | Intervention Type: DRUG; Name: CHF 1535 200/6 µg; Assigned to Arm(s): CHF 1535 200/6 µg | Intervention Type: DRUG; Name: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg; Assigned to Arm(s): CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
B: Arm Label: GW685698X; Type: EXPERIMENTAL; Interventions: Drug: GW685698X | Intervention Type: DRUG; Name: GW685698X; Assigned to Arm(s): GW685698X
C: Arm Label: Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI, Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: Metered Dose Inhaler, Device: Connected Inhaler System | Arm Label: Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI, Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: Metered Dose Inhaler, Device: Connected Inhaler System | Arm Label: Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FP/SAL, Drug: Tiotropium, Drug: Albuterol/salbutamol, Device: DISKUS DPI, Device: RESPIMAT inhaler, Device: Metered Dose Inhaler | Arm Label: Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FP/SAL, Drug: Tiotropium, Drug: Albuterol/salbutamol, Device: DISKUS DPI, Device: RESPIMAT inhaler, Device: Metered Dose Inhaler | Intervention Type: DRUG; Name: FF/UMEC/VI; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS | Intervention Type: DRUG; Name: FP/SAL; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DRUG; Name: Albuterol/salbutamol; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS, Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: ELLIPTA DPI; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS | Intervention Type: DEVICE; Name: DISKUS DPI; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: RESPIMAT inhaler; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: Metered Dose Inhaler; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS, Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: Connected Inhaler System; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS
D: Arm Label: MF/F MDI 400/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate/formoterol (MF/F) combination | Arm Label: MF/F MDI 200/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate/formoterol (MF/F) combination | Arm Label: MF MDI 400 mcg BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mometasone furoate MDI (MF MDI) | Intervention Type: DRUG; Name: Mometasone furoate/formoterol (MF/F) combination; Assigned to Arm(s): MF/F MDI 400/10 mcg BID | Intervention Type: DRUG; Name: Mometasone furoate/formoterol (MF/F) combination; Assigned to Arm(s): MF/F MDI 200/10 mcg BID | Intervention Type: DRUG; Name: Mometasone furoate MDI (MF MDI); Assigned to Arm(s): MF MDI 400 mcg BID

Answer: A