Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of COPD Following Hospitalization
Brief Summary: This trial is a randomized, double-blind, parallel-group, multicenter study to be conducted in the United States. The purpose of the study is to evaluate the rate of exacerbations of chronic obstructive pulmonary disease (COPD) following hospital discharge for an acute exacerbation of COPD, in patients receiving either fluticasone propionate/salmeterol combination product 250/50mcg BID or salmeterol 50mcg BID via DISKUS™ over 29 weeks. The study population will include patients hospitalized for an acute exacerbation of COPD. The target enrolment is 720 subjects at 80 study centers. The primary endpoint is the rate of exacerbation requiring hospitalization that occur more than 21 days post-discharge, emergency room visit or physician's office visit for an exacerbation of COPD requiring treatment with oral corticosteroids or oral corticosteroids and antibiotics. The secondary endpoint is the rate of COPD exacerbation requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination). Related efficacy endpoints include, time to first exacerbation of COPD requiring treatment with oral corticosteroids, antibiotics, and/or hospitalization (alone and in combination), pre-dose AM FEV1, the probability of premature withdrawal of subject from the study, and supplemental albuterol use, change in biomarkers of inflammation, including, surfactant protein D (SP-D), clara cell secretory protein 16 (CC-16) and high sensitivity C-reactive protein (hs-CRP). Health outcome assessments include domain scores evaluation for fatigue, dyspnea, emotional function and mastery, measured with the Chronic Respiratory Disease Questionnaire self-administered standardized format (CRQ-SAS); and symptoms (congestion, cough, phlegm, mucus, chest discomfort, shortness of breath and sleep disturbance), assessed by the EXAcerbations of Chronic pulmonary disease Tool (EXACT). Albuterol will be supplied to study subjects for use as-needed throughout the study. Safety will be assessed by monitoring of adverse events.


Options:
A: Arm Label: Indacaterol first; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium | Arm Label: Tiotropium first; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Indacaterol first, Tiotropium first | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Indacaterol first, Tiotropium first
B: Arm Label: ADVAIR DISKUS 250/50 mcg BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: ADVAIR DISKUS 250/50 mg BID | Arm Label: Serevent 50 mcg BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: SEREVENT 50 mcg BID | Intervention Type: DRUG; Name: ADVAIR DISKUS 250/50 mg BID; Assigned to Arm(s): ADVAIR DISKUS 250/50 mcg BID | Intervention Type: DRUG; Name: SEREVENT 50 mcg BID; Assigned to Arm(s): Serevent 50 mcg BID
C: Arm Label: QVA149 + placebo to tiotropium; Type: EXPERIMENTAL; Interventions: Drug: QVA149, Drug: Placebo to tiotropium, Drug: Salbutamol/albuterol | Arm Label: Tiotropium + placebo to QVA149; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Placebo to QVA149, Drug: Salbutamol/albuterol | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to QVA149, Drug: Placebo to tiotropium, Drug: Salbutamol/albuterol | Intervention Type: DRUG; Name: QVA149; Assigned to Arm(s): QVA149 + placebo to tiotropium | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium + placebo to QVA149 | Intervention Type: DRUG; Name: Placebo to QVA149; Assigned to Arm(s): Placebo, Tiotropium + placebo to QVA149 | Intervention Type: DRUG; Name: Placebo to tiotropium; Assigned to Arm(s): Placebo, QVA149 + placebo to tiotropium | Intervention Type: DRUG; Name: Salbutamol/albuterol; Assigned to Arm(s): Placebo, QVA149 + placebo to tiotropium, Tiotropium + placebo to QVA149
D: Arm Label: Aclidinium/Formoterol 400/6 μg; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate | Arm Label: Aclidinium/Formoterol 400/12 μg; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate | Arm Label: Aclidinium monotherapy 400 μg; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide | Arm Label: Formoterol monotherapy 12 μg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol Fumarate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium Bromide/Formoterol Fumarate; Assigned to Arm(s): Aclidinium/Formoterol 400/6 μg | Intervention Type: DRUG; Name: Aclidinium Bromide/Formoterol Fumarate; Assigned to Arm(s): Aclidinium/Formoterol 400/12 μg | Intervention Type: DRUG; Name: Aclidinium Bromide; Assigned to Arm(s): Aclidinium monotherapy 400 μg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Formoterol Fumarate; Assigned to Arm(s): Formoterol monotherapy 12 μg

Answer: B