Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: DB2114951: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD
Brief Summary: Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram \[mcg\] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.


Options:
A: Arm Label: CHF 5993 + Ultibro matched placebo; Type: EXPERIMENTAL; Interventions: Drug: CHF 5993 + Ultibro matched placebo, Procedure: Central spirometry, Other: COPD assessment test, Procedure: Local laboratory Assessments, Other: Saint George's Respiratory Questionnaire, Other: EXACT-pro questionnaire | Arm Label: Ultibro + CHF 5993 matched placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ultibro + CHF 5993 matched placebo, Procedure: Central spirometry, Other: COPD assessment test, Procedure: Local laboratory Assessments, Other: Saint George's Respiratory Questionnaire, Other: EXACT-pro questionnaire | Intervention Type: DRUG; Name: CHF 5993 + Ultibro matched placebo; Assigned to Arm(s): CHF 5993 + Ultibro matched placebo | Intervention Type: DRUG; Name: Ultibro + CHF 5993 matched placebo; Assigned to Arm(s): Ultibro + CHF 5993 matched placebo | Intervention Type: PROCEDURE; Name: Central spirometry; Assigned to Arm(s): CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo | Intervention Type: OTHER; Name: COPD assessment test; Assigned to Arm(s): CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo | Intervention Type: PROCEDURE; Name: Local laboratory Assessments; Assigned to Arm(s): CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo | Intervention Type: OTHER; Name: Saint George's Respiratory Questionnaire; Assigned to Arm(s): CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo | Intervention Type: OTHER; Name: EXACT-pro questionnaire; Assigned to Arm(s): CHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo
B: Arm Label: UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS arm; Type: EXPERIMENTAL; Interventions: Drug: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI, Drug: Placebo DISKUS | Arm Label: FSC via ACCUHALER/DISKUS + placebo NDPI arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS, Drug: Placebo NDPI | Intervention Type: DRUG; Name: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI; Assigned to Arm(s): UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS arm | Intervention Type: DRUG; Name: FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS; Assigned to Arm(s): FSC via ACCUHALER/DISKUS + placebo NDPI arm | Intervention Type: DRUG; Name: Placebo DISKUS; Assigned to Arm(s): UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS arm | Intervention Type: DRUG; Name: Placebo NDPI; Assigned to Arm(s): FSC via ACCUHALER/DISKUS + placebo NDPI arm
C: Arm Label: BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator; Type: EXPERIMENTAL; Interventions: Drug: BGF MDI 320/14.4/9.6 μg | Arm Label: GFF MDI (PT003) 14.4/9.6 μg ex-actuator; Type: EXPERIMENTAL; Interventions: Drug: GFF MDI (PT003) 14.4/9.6 μg | Arm Label: BFF MDI (PT009) 320/9.6 μg ex-actuator; Type: EXPERIMENTAL; Interventions: Drug: BFF MDI (PT009) 320/9.6 μg | Arm Label: Symbicort; Type: ACTIVE_COMPARATOR; Interventions: Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder | Intervention Type: DRUG; Name: BGF MDI 320/14.4/9.6 μg; Assigned to Arm(s): BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator | Intervention Type: DRUG; Name: GFF MDI (PT003) 14.4/9.6 μg; Assigned to Arm(s): GFF MDI (PT003) 14.4/9.6 μg ex-actuator | Intervention Type: DRUG; Name: BFF MDI (PT009) 320/9.6 μg; Assigned to Arm(s): BFF MDI (PT009) 320/9.6 μg ex-actuator | Intervention Type: DRUG; Name: Symbicort® Turbuhaler® (TBH) Inhalation Powder; Assigned to Arm(s): Symbicort
D: Arm Label: Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium bromide/Vilanterol, Drug: Placebo ACCUHALER/DISKUS | Arm Label: Fluticasone propionate/Salmeterol + placebo NDPI; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/Salmeterol, Drug: Placebo NDPI | Intervention Type: DRUG; Name: Umeclidinium bromide/Vilanterol; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Placebo ACCUHALER/DISKUS; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Fluticasone propionate/Salmeterol; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI | Intervention Type: DRUG; Name: Placebo NDPI; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI

Answer: B