Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler Compared With Usual Maintenance Therapy in Subjects With Asthma
Brief Summary: This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.


Options:
A: Mean change from baseline (pre-dose) FEV1 in trough (mean of the FEV1 values obtained 23 and 24 hours after dosing) FEV1 (on going)
B: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
C: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. (Baseline (Day 0) and Week 24)
D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period (From the start of study medication until Visit 11 (Week 52)/Early Withdrawal); Number of Participants With Severe Asthma Exacerbations During the Treatment Period (From the start of study medication until Visit 11 (Week 52)/Early Withdrawal); Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion (Baseline; Week 12, Week 28, and Week 52/Early Withdrawal); Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline (Baseline and Week 12); Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline (Baseline and Week 28); Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline (Baseline and Week 52); Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline (From Baseline until Visit 11/Early Withdrawal (52 weeks)); Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP) (From Baseline until Visit 11/Early Withdrawal (52 weeks)); Maximum Change From Baseline in Pulse Rate (From Baseline until Visit 11/Early Withdrawal (52 weeks)); Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52 (Baseline; Week 28, and Week 52); Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52 (Baseline; Week 28 and Week 52); Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF) (Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal); Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data (0-24 hours at Screening, Day 1, Week 28, and Week 52); Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data (0-24 hours at Screening, Day 1, Week 28, and Week 52)

Answer: C