Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Co-Primary Outcomes/Efficacy Variables:

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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: HZA Title: A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multi-centre study of Fluticasone Furoate/GW Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Rationale: It is well accepted that inhaled corticosteroids reduce asthma morbidity and mortality. Furthermore, studies have demonstrated that twice-daily long-acting beta2-agonist (LABA) treatment added to twice-daily inhaled corticosteroid (ICS) treatment can further improve asthma control compared with ICS alone. International guidelines such as those issued by Global Initiative for Asthma (GINA) and the National Heart, Lung and Blood Institute (NHLBI) advocate the use of inhaled LABAs in combination with ICS as maintenance therapy in asthma for subjects who remain symptomatic on low to mid doses of ICS. The ICS/LABAs that are currently available require twice-daily administration. The availability of a once-daily ICS/LABA treatment would be expected to help improve subject compliance and therefore improve asthma control. This study compared the efficacy and safety of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100 mcg/25 mcg, Fluticasone Furoate (FF) Inhalation Powder 100 mcg, and placebo; all administered once-daily via a novel dry powder inhaler (NDPI) in the evening. Phase: III Study Period: 20 August October 2011 Study Design: This was a multi-centre, stratified, randomised, double-blind, placebo-controlled (with rescue medication), parallel-group study to compare the efficacy and safety of Fluticasone Furoate/GW Inhalation Powder 100mcg/25mcg, Fluticasone Furoate (FF) Inhalation Powder 100mcg and placebo, all administered once-daily in the evening. Subjects participated in the study for up to a maximum of 18 weeks (including screening, treatment and follow-up visit). Centres: Sixty four centres in 6 countries Indication: Asthma Treatment: Subjects meeting the eligibility criteria were stratified according to their pre-screening medication (ICS or ICS/LABA combination) at Visit 3 and then randomised to the treatment phase of the study where they received one of the following three study treatments via NDPI once-daily in the evening for 84 days (12 weeks): FF/VI Inhalation Powder 100 mcg/25 mcg, FF Inhalation Powder 100 mcg placebo Objectives: To compare the efficacy and safety of FF/VI Inhalation Powder 100 mcg/25 mcg and FF 100 mcg both administered once-daily in the evening in adolescent and adult subjects, 12 years of age and older, with persistent bronchial asthma over a 12-week treatment period Co-Primary Outcomes/Efficacy Variables: Mean change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in 1 second (FEV 1 ) at the end of the 84-day treatment period in all subjects. Weighted mean serial FEV 1 over 0-24 hours post-dose calculated in the subset of subjects performing serial FEV 1 at the end of the 84-day double-blind treatment period. 24-hour serial FEV 1 included predose assessment within 5 minutes prior to dosing, and post-dose assessments after 5, 15, 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23 and 24 hours. Secondary Outcome/Efficacy Variable(s): Powered secondary endpoint: Mean change from baseline in the percentage of rescue-free 24-hour periods during the 12-week 1

2 treatment period, captured daily via electronic subject diary (ediary). Secondary endpoints: Change from baseline in the percentage of symptom-free 24-hour periods during the 12-week treatment period, captured daily via ediary. Change from baseline in total Asthma Quality of Life Questionnaire +12 (AQLQ [+12]) score at the end of 12-week treatment period. The number of withdrawals due to lack of efficacy during the 12-week treatment period. Statistical Methods: The sample size calculation assumed a 5% withdrawal rate in the first 2 weeks of the study and a 15% withdrawal rate over the whole treatment period of the study. This ensured 180 subjects per arm for analysis of trough FEV 1 and % rescue-free 24-hour periods, and ensured 96 subjects per arm for analysis of weighted mean serial FEV 1 over 0-24 hours at Week 12 in a subset population. The overall power of the study to detect treatment differences across the specified treatment comparisons for the co-primary endpoints and the nominated secondary endpoint was 83%. A 2-sided 5% risk associated with incorrectly rejecting any of the null hypotheses (significance level) was considered acceptable for this study. In order to account for multiplicity, a step-down closed testing procedure was applied whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been achieved for the previous comparison in the hierarchy. If a given statistical test failed to reject the null hypothesis of no treatment difference at the significance level of 0.05, then all tests lower down in the hierarchy were interpreted as descriptive only. The primary treatment comparisons were between FF/VI 100/25 and FF 100, between FF/VI and placebo and between FF 100 and placebo for the co-primary efficacy endpoints. The primary analyses were performed using Analysis of Covariance (ANCOVA). For the analysis of trough FEV 1, Last Observation Carried Forward (LOCF) was used to impute missing data. A supporting analysis was also performed using a Repeated Measures Mixed Model. Missing data were not implicitly imputed in this analysis; however, all non-missing data for a subject were used within the analysis to estimate the Day 84 treatment effects. For the co-primary endpoints, estimated treatment differences for treatment comparisons were presented together with 95% CIs for the mean differences and p-values for comparisons, as appropriate. Unless otherwise stated, all models used for the efficacy and safety analyses were adjusted for baseline, region, sex, age, and treatment group. The Intent-to-Treat (ITT) Population comprised all subjects randomised to treatment and who received at least one dose of study medication and was the primary population for all efficacy and safety analyses (excluding urinary cortisol analyses which had a separate, Urinary Cortisol (UC) Population comprising subjects whose urine samples did not have confounding factors that affected the interpretation of results). The primary comparisons were supported by the Per Protocol (PP) Population which comprised all subjects in the ITT Population who did not have any full protocol deviations. Protocol deviations could be either full or partial. Subjects with only partial deviations were considered part of the PP Population but from the date of their deviation onwards, their data were excluded. 2

3 Study Population: Male and female subjects (female subjects were of non-childbearing potential or of childbearing potential using an acceptable method of birth control consistently and correctly), 12 years old (or 18 years old in certain countries to meet country regulations), with a current asthma diagnosis: prebronchodilator % predicted FEV 1 40 to 90% with post-salbutamol/albuterol reversibility 12% and 200 ml, using ICS or ICS/LABA combination for at least 12 weeks prior to Visit 1 (Screening Visit). In addition, all subjects were either to have been maintained on a stable low to mid ICS dose (Fluticasone Propionate [FP] 100 to 250 mcg twice daily or equivalent) for at least 4 weeks prior to Visit 1, or to have been maintained on a stable dose of an ICS/LABA low-dose combination product (e.g., fluticasone propionate/salmeterol 100/50 twice-daily or equivalent via other combination products or via separate inhalers) for at least 4 weeks prior to Visit 1. Subjects had no other respiratory disorders diagnosed, no exacerbations requiring oral corticosteroids within 12 weeks of Visit 1 (Screening Visit) or that resulted in overnight hospitalisation requiring additional treatment for asthma within 6 months prior to Visit 1 and no other concurrent abnormalities that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. Subjects were randomised if they had an evening pre-dose FEV 1 between 40 and 90% at Visit 3 (Randomisation Visit) and demonstrated day or night-time asthma symptom scores 1 and/or daily salbutamol/albuterol use on 4 or more days in the last consecutive 7 days of Run-in Period and compliance with ediary completion (defined as completion of all questions on 4 of the last 7 consecutive days of the Run-In Period). Subjects were not randomised if they had clinically significant abnormalities in clinical laboratory tests, 12-lead ECG, or had occurrence of culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the Run-in Period that led to a change in asthma management or, in the opinion of the investigator, was expected to affect the subject s asthma status or the subject s ability to participate in the study, asthma exacerbations requiring systemic corticosteroids or changed their asthma medication between Visit 1 and Visit 3 or evidence of oral candidiasis. Study Completion and Withdrawals Planned, N Randomised, N Number of Subjects (ITT): Completed, 151 (74) 185 (90) 179 (89) Total Number Subjects Withdrawn, N (%) 52 (26) 20 (10) 22 (11) Withdrawn due to Adverse Events 1 (<1) 0 2 (<1) Withdrawn due to Lack of Efficacy 32 (16) 6 (3) 7 (3) Withdrawn for other reasons 19 (9) 14 (7) 13 (6) Demographics N (ITT) Females: Males 111:92 126:79 116:85 Mean Age, years (SD) 38.1 (16.49) 40.4 (16.78) 40.7 (16.38) White, 169 (83) 171 (83) 172 (86) Adolescents 33 (16) 28 (14) 21 (10) Primary Efficacy Results: Change from baseline in trough FEV 1 (LOCF) at Week 12 n LS Mean Change from Baseline (SE) (0.0310) (0.0302) (0.0304) Difference between column versus placebo % CI (0.051, 0.222) (0.087, 0.258) p-value <

4 Difference between column versus FF % CI (-0.048, 0.120) p-value Weighted mean FEV 1 (0-24h) n LS Mean Change from Baseline (SE) (0.0456) (0.0432) (0.0430) Difference between column versus placebo % CI (0.062, 0.310) (0.178, 0.426) p-value <0.001 Difference between column versus FF % CI (-0.005, 0.236) p-value Secondary Outcome Variable(s): Change from baseline in percentage of rescue-free 24-hour periods (Weeks 1-12) n Difference between column versus placebo % CI (2.4, 15.0) (13.0, 25.6) Difference between column versus FF % CI (4.3, 16.8) Change from baseline in percentage of symptom-free 24-hour periods (Weeks 1-12) n Difference between column versus placebo % CI (-0.1, 11.8) (12.0, 23.9) Difference between column versus FF % CI (6.2, 18.1) Change from baseline in total AQLQ (+12) score at Week 12 n Difference between column versus placebo % CI (-0.01, 0.31) (0.13, 0.46) Difference between column versus FF % CI (-0.01, 0.30) Number of withdrawals due to lack of efficacy during (Weeks 1-12) n Number of subjects whose primary reason for withdrawal was lack of efficacy, n(%) 32 (16) 6 (3) 7 (3) Safety Results: Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected during the treatment period (Weeks 1 to 12) until Follow-up (Visit 8) N=203 N=205 N=201 Most Frequent Adverse Events On-Therapy Subjects with any AE(s), n(%) 43 (21) 52 (25) 59 (29) Nasopharyngitis 15 (7) 14 (7) 20 (10) Headache 8 (4) 9 (4) 10 (5) 4

5 Dysphonia 0 3 (1) 5 (2) Back pain 0 5 (2) 1 (<1) Oral candidiasis 0 2 (<1) 4 (2) Dyspnoea 4 (2) 0 0 Upper respiratory tract infection 0 4 (2) 3 (1) Oropharyngeal pain 3 (1) 4 (2) 4 (2) Bronchitis 3 (1) 0 1 (<1) Dyspepsia 2 (<1) 3 (1) 0 Toothache 0 3 (1) 1 (<1) Epistaxis (1) Serious Adverse Events - On-Therapy [n considered by the investigator to be related to study medication] Subjects with on-therapy SAEs, [number of subjects with related events] no fatal SAEs reported Any event 0 1 (<1) [0] 0 Pancreatitis 0 1 (<1) [0] 0 Conclusion: Once-daily treatment with either FF/VI 100/25 or FF 100 demonstrated statistically significant improvements versus placebo in lung function, as measured by FEV 1. Based on the data from the co-primary endpoints, it cannot be concluded that there is a statistically significant incremental benefit in lung function from the VI component in the FF/VI combination over FF alone. The incidence of on-treatment AEs ranged from 21% to 29% with a low incidence of drug-related AEs (ranging from 1% to 7%). The highest proportion of ontreatment AEs of special interest were due to local steroid effects (1% to 6%). Four SAEs were reported throughout the study and by subjects randomised to active treatment, but only one was reported ontreatment (pancreatitis, FF 100). The remaining SAEs were reported during run-in (cystitis) and follow-up (appendicitis and prostate cancer). None of the SAEs were fatal, led to withdrawal or were considered related to the study drug. 5

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