Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects.

Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability.

At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period.

A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.


Options:
A: Arm Label: FF/VI Inhalation Powder NDPI; Type: EXPERIMENTAL; Interventions: Drug: FF/VI 100/25 Inhalation Powder NDPI, Drug: Placebo Inhalation Powder ACCUHALER/DISKUS, Drug: Salbutamol as needed | Arm Label: Fluticasone Propionate/Salmeterol Inhalation Powder; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS, Drug: Placebo Inhalation Powder NDPI, Drug: Salbutamol as needed | Intervention Type: DRUG; Name: FF/VI 100/25 Inhalation Powder NDPI; Assigned to Arm(s): FF/VI Inhalation Powder NDPI | Intervention Type: DRUG; Name: Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS; Assigned to Arm(s): Fluticasone Propionate/Salmeterol Inhalation Powder | Intervention Type: DRUG; Name: Placebo Inhalation Powder NDPI; Assigned to Arm(s): Fluticasone Propionate/Salmeterol Inhalation Powder | Intervention Type: DRUG; Name: Placebo Inhalation Powder ACCUHALER/DISKUS; Assigned to Arm(s): FF/VI Inhalation Powder NDPI | Intervention Type: DRUG; Name: Salbutamol as needed; Assigned to Arm(s): FF/VI Inhalation Powder NDPI, Fluticasone Propionate/Salmeterol Inhalation Powder
B: Arm Label: tiotropium + olodaterol low dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium, Drug: olodaterol | Arm Label: tiotropium + olodaterol high dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium, Drug: olodaterol | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium + olodaterol low dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol low dose
C: Arm Label: NVA237; Type: EXPERIMENTAL; Interventions: Drug: NVA237, Drug: Placebo to tiotropium, Drug: salbutamol/albuterol | Arm Label: Tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Placebo to NVA237 | Intervention Type: DRUG; Name: NVA237; Assigned to Arm(s): NVA237 | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium | Intervention Type: DRUG; Name: Placebo to tiotropium; Assigned to Arm(s): NVA237 | Intervention Type: DRUG; Name: Placebo to NVA237; Assigned to Arm(s): Tiotropium | Intervention Type: DRUG; Name: salbutamol/albuterol; Assigned to Arm(s): NVA237
D: Arm Label: tiotropium + olodaterol high dose; Type: EXPERIMENTAL; Interventions: Drug: olodaterol, Drug: tiotropium | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium

Answer: A