Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-national, Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study With GSK 573719 as Monotherapy in Adult Subjects With Asthma
Brief Summary: This is a multi-national, randomized, double-blind, 3-period crossover, incomplete block design to evaluate 5 once-daily and 2 twice-daily doses of GSK573719 in combination with placebo. The study will explore the dose range of GSK573719 in asthmatic subjects who are currently using non-ICS controller medications. Subjects will participate in the study for up to a maximum of 14 weeks. At randomization subjects will be stratified by age to ensure adequate exposure to GSK573719 throughout the expected age range. The primary endpoint will be trough FEV1 obtained 24 hours after the last morning dose on Day 14 of each treatment sequence.

A sub-group of subjects at selected sites (approximately 30% of the total population) will have additional serial assessments for spirometry, ECG and Holter, and pharmacokinetic sampling at the start and end of each treatment period. Safety assessments will include monitoring for adverse events, laboratory tests, asthma symptom assessments and twice daily PEF evaluation. Consenting subjects will have a blood sample taken for pharmacogenetic analysis.


Options:
A: Arm Label: Foster® NEXThaler®; Type: EXPERIMENTAL; Interventions: Drug: Foster® NEXThaler® 100/6 µg/unit dose | Arm Label: Seretide® Accuhaler®; Type: ACTIVE_COMPARATOR; Interventions: Drug: Seretide® Accuhaler® 250/50 µg/actuation | Intervention Type: DRUG; Name: Foster® NEXThaler® 100/6 µg/unit dose; Assigned to Arm(s): Foster® NEXThaler® | Intervention Type: DRUG; Name: Seretide® Accuhaler® 250/50 µg/actuation; Assigned to Arm(s): Seretide® Accuhaler®
B: Arm Label: QMF149 Twisthaler® 500/400; Type: EXPERIMENTAL; Interventions: Drug: QMF149 Twisthaler® | Arm Label: Mometasone Twisthaler®; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mometasone Twisthaler® | Intervention Type: DRUG; Name: QMF149 Twisthaler®; Assigned to Arm(s): QMF149 Twisthaler® 500/400 | Intervention Type: DRUG; Name: Mometasone Twisthaler®; Assigned to Arm(s): Mometasone Twisthaler®
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: GSK573719 15.6 mcg; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Arm Label: GSK573719 31.25 mcg; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Arm Label: GSK573719 62.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Arm Label: GSK573719 125 mcg; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Arm Label: GSK573719 250 mcg; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Arm Label: GSK573719 15.6 mcg twice-daily; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Arm Label: GSK573719 31.25 mcg twice daily; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Arm Label: Matched Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: GSK573719 Active treatment or Placebo, Procedure: GSK573719 (Sub-group cohort), Drug: Salbutamol/Albuterol | Intervention Type: DRUG; Name: GSK573719 Active treatment or Placebo; Assigned to Arm(s): GSK573719 125 mcg, GSK573719 15.6 mcg, GSK573719 15.6 mcg twice-daily, GSK573719 250 mcg, GSK573719 31.25 mcg, GSK573719 31.25 mcg twice daily, GSK573719 62.5 mcg, Matched Placebo | Intervention Type: PROCEDURE; Name: GSK573719 (Sub-group cohort); Assigned to Arm(s): GSK573719 125 mcg, GSK573719 15.6 mcg, GSK573719 15.6 mcg twice-daily, GSK573719 250 mcg, GSK573719 31.25 mcg, GSK573719 31.25 mcg twice daily, GSK573719 62.5 mcg, Matched Placebo | Intervention Type: DRUG; Name: Salbutamol/Albuterol; Assigned to Arm(s): GSK573719 125 mcg, GSK573719 15.6 mcg, GSK573719 15.6 mcg twice-daily, GSK573719 250 mcg, GSK573719 31.25 mcg, GSK573719 31.25 mcg twice daily, GSK573719 62.5 mcg, Matched Placebo

Answer: D