Please select the outcome measures that correspond to the clinical trial below.
Title: Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD
Brief Summary: This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] Once daily \[QD\]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG. BREEZHALER is a registered trademark of Novartis AG.


Options:
A: Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure. (PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period); Systemic exposure of FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI 100mcg /62.5mcg /25mcg compared with FF/VI 100mcg /25mcg and UMEC/VI 62.5mcg /25mcg (PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.)
B: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)
C: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)
D: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) (From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)); Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46)); Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period (Day 1 of each treatment period (up to Study Day 46))

Answer: B