Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Single Dose, Four Way Cross-over Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol Following Single Inhaled Doses of Umeclidinium/Vilanterol Blend + Fluticasone Furoate, Umeclidinium + Vilanterol, Fluticasone Furoate + Vilanterol and Fluticasone Furoate + Umeclidinium in Healthy Subjects
Brief Summary: This is a double-blind, single dose (four inhalations), four-way cross over study in healthy subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics (PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a two strip configuration. The NDPI will be configured with different combinations of each compound and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI device. Study drug will be administered through the inhaled route to healthy subjects in single doses (four inhalations). Each subject will receive treatment in a randomized order Treatment A FF (400 microgram \[µg\]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg) and VI (100 µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and UMEC (500 µg) over four treatment periods. Each treatment period will be separated by a washout of 7 to 21 days. After the four treatment periods, a follow up visit will take place 7 to 21 days following the final dose of study medication and the maximum duration a subject will be involved in the study is eighteen weeks.

Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout the study.


Options:
A: Arm Label: GSK573719/GW642444 125/25; Type: EXPERIMENTAL; Interventions: Drug: GSK573719/GW642444 125/25 | Arm Label: GSK573719/GW642444 62.5/25; Type: EXPERIMENTAL; Interventions: Drug: GSK573719/GW642444 62.5/25 | Arm Label: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 | Arm Label: tiotropium bromide; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium bromide | Intervention Type: DRUG; Name: GSK573719/GW642444 125/25; Assigned to Arm(s): GSK573719/GW642444 125/25 | Intervention Type: DRUG; Name: GSK573719/GW642444 62.5/25; Assigned to Arm(s): GSK573719/GW642444 62.5/25 | Intervention Type: DRUG; Name: GSK573719; Assigned to Arm(s): GSK573719 | Intervention Type: DRUG; Name: tiotropium bromide; Assigned to Arm(s): tiotropium bromide
B: Arm Label: COPD subjects; Type: N/A; Interventions: Other: Novel endpoint determination | Arm Label: Smoker controls; Type: N/A; Interventions: Other: Novel endpoint determination | Arm Label: Non-smoker controls; Type: N/A; Interventions: Other: Novel endpoint determination | Intervention Type: OTHER; Name: Novel endpoint determination; Assigned to Arm(s): COPD subjects, Non-smoker controls, Smoker controls
C: Arm Label: UMEC/VI+FF; Type: EXPERIMENTAL; Interventions: Drug: UMEC /VI, Drug: FF | Arm Label: UMEC+VI; Type: EXPERIMENTAL; Interventions: Drug: UMEC, Drug: VI | Arm Label: FF+VI; Type: EXPERIMENTAL; Interventions: Drug: VI, Drug: FF | Arm Label: FF+UMEC; Type: EXPERIMENTAL; Interventions: Drug: UMEC, Drug: FF | Intervention Type: DRUG; Name: UMEC /VI; Assigned to Arm(s): UMEC/VI+FF | Intervention Type: DRUG; Name: UMEC; Assigned to Arm(s): FF+UMEC, UMEC+VI | Intervention Type: DRUG; Name: VI; Assigned to Arm(s): FF+VI, UMEC+VI | Intervention Type: DRUG; Name: FF; Assigned to Arm(s): FF+UMEC, FF+VI, UMEC/VI+FF
D: Arm Label: FF/VI 100/25 mcg + UMEC (62.5mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + UMEC (125mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + Placebo; Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: Placebo | Intervention Type: DRUG; Name: FF; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: VI; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: UMEC; Assigned to Arm(s): FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo

Answer: C