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In February 2013, Glaxosmithkline (GSK) Announced a Commitment to Further Clinical Transparency Through the Public Disclosure Of

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In February 2013, Glaxosmithkline (GSK) Announced a Commitment to Further Clinical Transparency Through the Public Disclosure Of In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The following guiding principles have been applied to the disclosure: Information will be excluded in order to protect the privacy of patients and all named persons associated with the study Patient data listings will be completely removed* to protect patient privacy. Anonymized data from each patient may be made available subject to an approved research proposal. For further information please see the Patient Level Data section of the GSK Clinical Study Register. Aggregate data will be included; with any direct reference to individual patients excluded *Complete removal of patient data listings may mean that page numbers are no longer consecutively numbered CONFIDENTIAL RM2004/00374/00 The GlaxoSmithKline group of companies SAM40065 The GlaxoSmithKline group of companies A multicenter, randomized, double-blind, parallel group, 40-week comparison of asthma control using bronchial hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either fluticasone propionate/salmeterol DISKUS BID or fluticasone propionate DISKUS BID (or placebo BID if asymptomatic) Clinical Study Report for Study SAM40065 (Development Phase IV) Document Number: RM2004/00374/00 Compound Number: CCI18781+GR33343 Investigational Product: ADVAIR DISKUS Generic Drug Name: Fluticasone propionate/salmeterol combination product Indication Studied: Initiation Date: 17Jan2003 Completion Date: 19Oct2004 Date of Report: August 2005 Sponsor Signatory: MD (and Medical Officer) Respiratory Medicine Development Center GlaxoSmithKline This study was performed in compliance with Good Clinical Practices including the archiving of essential documents. Copyright 2005 the GlaxoSmithKline group of companies. All rights reserved. Unauthorized copying or use of this information is prohibited. 1 CONFIDENTIAL RM2004/00374/00 SAM40065 Synopsis Document Number: RM2004/00374/00 Study Number: SAM40065 Title: A multicenter, randomized, double-blind, parallel group, 40-week comparison of asthma control using bronchial hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either fluticasone propionate/salmeterol DISKUS BID or fluticasone propionate DISKUS BID (or placebo BID if asymptomatic) Investigator(s): Multicenter study Study center(s): 46 sites in the US (39 sites randomized subjects), 3 sites in Latin America (3 sites randomized subjects), and 2 sites in Latvia, (2 sites randomized subjects). Publication(s): None at the time of this report Study period: 17Jan2003 - 19Oct2004 Phase of Development: IV Objectives: The objective of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness (BHR) could be achieved and maintained at a lower total daily dose of inhaled corticosteroids with ADVAIR DISKUS BID compared with FLOVENT DISKUS BID in adult and adolescent subjects with persistent asthma. Methodology: This was a 40-week, randomized, double-blind, parallel group trial conducted on an outpatient basis. Subjects were provided with albuterol inhalation aerosol for use as needed throughout the trial. Subjects who met the entry criteria entered a 2-week run-in period in which the subjects continued their allowed non-corticosteroid controller or inhaled corticosteroid treatment. Subjects who completed the 2-week run-in period and met all entry criteria were randomly assigned to receive one of the following double-blind study treatments for 40 weeks, with doses subject to adjustment every 8 weeks. Fluticasone propionate/salmeterol DISKUS (BHR strategy, FSCBHR) Fluticasone propionate DISKUS (BHR strategy, FPBHR) Fluticasone propionate DISKUS (Reference strategy, FPREF) The starting dose at Visit 2 for each subject was based on asthma symptoms, lung function, and bronchodilator use recorded on the diary cards during the run-in period (Reference strategy) and in addition, BHR measures (BHR strategy subjects only). At Visits 3 – 6, the dose of study treatment was re-assessed and left unchanged, increased, or decreased based on changes in lung function and other asthma assessment parameters as they correlated with severity scores in the Reference and BHR strategies. Double-blind treatment was started 14±2 days after the Screening Visit and continued for 40 weeks. Subjects returned to the clinic during the double-blind treatment period for study visits every 8 weeks. 2 CONFIDENTIAL RM2004/00374/00 SAM40065 Title: A multicenter, randomized, double-blind, parallel group, 40-week comparison of asthma control using bronchial hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either fluticasone propionate/salmeterol DISKUS BID or fluticasone propionate DISKUS BID (or placebo BID if asymptomatic) Number of subjects: A total of 449 subjects were randomized. Of the 150 subjects in the FSCBHR treatment group, 112 (75%) completed the study, of the 150 subjects in the FPBHR treatment group, 100 (67%) completed the study, and of the 149 subjects in the FPREF treatment group, 110 (74%) completed the study. Diagnosis and main criteria for inclusion: Subjects were male or female 12 years of age and older with a diagnosis of asthma for at least 3 months and were treated with short-acting beta2- agonists, anticholinergics, or inhaled corticosteroids for at least 1 month prior to Screening. All subjects were required to have an FEV1 of 60% to 95% of predicted normal and ≥12% reversibility within 30 minutes following 2 puffs of albuterol at Screening. Treatment administration: Subjects who completed the 2-week run-in period and met all entry criteria were randomly assigned to receive one of the following double-blind treatments for 8 weeks. • Fluticasone propionate/salmeterol DISKUS (BHR strategy, FSCBHR) Placebo DISKUS BID 100/50mcg BID 250/50mcg BID 500/50mcg BID • Fluticasone propionate DISKUS (BHR strategy, FPBHR) Placebo DISKUS BID 100mcg BID 250mcg BID 500mcg BID • Fluticasone propionate DISKUS (Reference strategy, FPREF) Placebo DISKUS BID 100mcg BID 250mcg BID 500mcg BID Albuterol inhalation aerosol was provided for as needed relief of acute asthma symptoms during the study. Criteria for evaluation: The primary efficacy endpoint was the average total daily inhaled corticosteroid treatment dose over the treatment period. The secondary, related, and biomarker efficacy endpoints were based on subject recorded diary card data (PEF, albuterol use, and asthma symptom scores), PC20, and clinic FEV1. 3 CONFIDENTIAL RM2004/00374/00 SAM40065 Title: A multicenter, randomized, double-blind, parallel group, 40-week comparison of asthma control using bronchial hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either fluticasone propionate/salmeterol DISKUS BID or fluticasone propionate DISKUS BID (or placebo BID if asymptomatic) Statistical methods: The primary efficacy measure of this study was the average total daily dose of ICS over the duration of the study, summarized in terms of area under the curve (AUC) over time. The null hypothesis of interest was that the average total daily ICS dose in micrograms of FSC (BHR strategy, FSCBHR) would be the same as the average total daily ICS dose in micrograms of FP (BHR strategy, FPBHR). The alternative hypothesis was that the average total daily ICS dose in micrograms of FSCBHR was different that the average total daily ICS dose in micrograms of FPBHR. The estimated mean dose of ICS was derived from estimates of the proportion of time subjects on each treatment would spend in each of the four Severity Classes. From these assumed proportions of time in each Severity Class, the mean dose of FSCBHR was estimated to be 170.5mcg BID [(0.02 x 0) + (0.53 x 100) + (0.43 x 250) + (0.02 x 500)] and the mean dose of FPBHR to be 259.5mcg BID [0 + (0.07 x 100) + (0.85 x 250) + (0.08 x 500)]. The standard deviation of that difference was estimated as one-fourth the range of possible ICS doses, or 125mcg [(500 – 0)/4]. Based on a two-group t-test with a significance level of α=0.05, and using the estimates described above, a sample size of 43 subjects in each group would have 90% power to detect a difference in means of 89mcg (the difference between the FSC mean of 170.5mcg and the FP mean of 259.5mcg). It was anticipated that the variability of these results could be greater than the estimated 125cg, so the sample size for this study was increased to 100 subjects per group. Note that a hypothesized treatment difference of 89mcg BID is equal to a treatment difference of 178mcg of total daily dose. Primary efficacy results are presented in this report in terms of total daily dose. 4 CONFIDENTIAL RM2004/00374/00 SAM40065 Title: A multicenter, randomized, double-blind, parallel group, 40-week comparison of asthma control using bronchial hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either fluticasone propionate/salmeterol DISKUS BID or fluticasone propionate DISKUS BID (or placebo BID if asymptomatic) Summary: Efficacy • Asthma control and reduced bronchial hyperresponsiveness (BHR) were achieved and maintained at a lower total daily dose of inhaled corticosteroids with FSC BID compared with FP BID. This observation was not statistically significant. • Except for FEV1 at endpoint for FSCBHR vs. FPBHR,
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