GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Diskus® in patients with COPD PR Newswire LONDON, May 19, 2014 LONDON, May 19, 2014 /PRNewswire/ --GlaxoSmithKline plc (LSE: GSK) today presented data at the American Thoracic Society (ATS) from a late-stage clinical study. In this study the safety and efficacy of the addition of a long-acting muscarinic antagonist (also known as an anticholinergic), umeclidinium 'UMEC' 62.5mcg (Incruse™ ^ Ellipta^®) and UMEC 125mcg, to the inhaled corticosteroid and long-acting beta2 agonist combination medicine, fluticasone proprionate and salmeterol 'FSC 250/50 mcg' (Advair ^® Diskus^®), was evaluated in chronic obstructive pulmonary disease (COPD) patients over 12 weeks. The study showed that, for the primary endpoint of trough FEV1 at Day 85, the addition of UMEC (at either dose) to FSC 250/50 mcg resulted in a statistically significant improvement in lung function when compared with placebo added on to FSC 250/50 mcg, in patients with COPD. The addition of UMEC (at either dose) to FSC 250/50mcg also demonstrated statistically significant improvements in secondary efficacy endpoints of 0-6 hour weighted mean FEV1 at Day 84 and mean number of puffs of rescue medicine per day (weeks 1-12) compared with the addition of placebo to FSC 250/50 mcg. Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said: "We are pleased to be able to share these results with physicians from across the world at this international congress. The ATS provides a forum for scientific discussion and we look forward to understanding the scientific and healthcare communities' perspectives of these new data." There were no notable differences between UMEC (at either dose) added to FSC 250/50 mcg and placebo added to FSC 250/50 mcg in incidence rates of on-treatment adverse events or in changes from baseline in vital signs. About the study This was a 12-week, randomised, double-blind, parallel-group study. Approximately 600 eligible patients were randomised 1:1:1 to once-daily UMEC 62.5 mcg, UMEC 125 mcg, or placebo, added to FSC (250/50 mcg twice daily). UMEC and placebo were administered via Ellipta dry powder inhaler and FSC via Diskus^® inhaler. The primary endpoint was trough forced expiratory volume in one second (FEV1) on Day 85. Secondary endpoints were 0–6-hour post-dose weighted mean (WM) FEV1 on Day 84 and rescue albuterol use (percentage of rescue-free days and puffs/day). Safety endpoints included the incidence of on-treatment adverse events (AEs), vital signs and COPD exacerbations. Compared with placebo added to FSC 250/50 mcg, both doses of UMEC (62.5 mcg and 125 mcg) added to FSC 250/50 mcg, demonstrated statistically significant improvements in trough FEV1 at Day 85 (62.5 mcg=147mL; 125 mcg=138mL both p<0.001) and 0-6-hour WM FEV1 at Day 84 (62.5 mcg=164mL; 125 mcg=160mL; both p<0.001). During weeks 1-12 for both the UMEC added to FSC groups, rescue albuterol use was reduced by an average of 0.3 puffs/day compared with placebo added to FSC (both p<0.05). Patients in the UMEC added to FSC treatment groups experienced, on average a greater percentage of rescue-free days and greater increases from baseline in percentage of rescue-free days (62.5 mcg= 59.4% and 13.3%; 125 mcg= 56.1% and 11.1 % respectively) compared with placebo added to FSC (49.7% and 4.9% respectively). No formal statistical analysis was performed on this endpoint. Incidences of on-treatment adverse events (AEs) were similar across all groups (62.5 mcg + FSC 250/50 mcg =38%; 125 mcg + FSC 250/50 mcg = 37%; placebo + FSC 250/50 mcg =41%); headache and nasopharyngitis were most commonly reported (reported by 3% or more subjects in any treatment group): headache: 62.5 mcg + FSC 250/50 mcg =4%; 125 mcg + FSC 250/50 mcg = 7%; placebo + FSC 250/50 mcg =5% and nasopharyngitis: 62.5 mcg + FSC 250/50 mcg =2%; 125 mcg + FSC 250/50 mcg = 2%; placebo + FSC 250/50 mcg =5%. Fewer on-treatment COPD exacerbations and cardiovascular AEs of special interest were reported with UMEC added to FSC 250/50 mcg (62.5 mcg=4% and <1%, respectively; 125 mcg=3% and 1%) compared with placebo added to FSC 250/50 mcg (6% and 2%). There was no incidence of pneumonia reported in the placebo + FSC 250/50 mcg group, one incidence reported in the UMEC 62.5 mcg + FSC 250/50 mcg group and two in the UMEC 125 mcg + FSC 250/50 mcg group. One death in the UMEC 125 mcg added to FSC 250/50 mcg group was reported as study-drug related. There were no deaths reported in the other treatment groups. Umeclidinium is only approved for use in the US, Canada and Europe. It is not approved anywhere else in the world. Umeclidinium 125mcg is not an approved dose anywhere in the world. The full results of this study has been posted onto clinicaltrials.gov and GSK's Clinical Trials Register For full US Prescribing Information including BOXED WARNING and/or Medication Guide for Advair Diskus, please visit: http://www.gsk.com/products/index.htm Advair Diskus250/50 is the approved dose for treatment of COPD in the US. Seretide 500/50 is the licenseddose for treatment of COPD inthe European Union. About Incruse Ellipta Incruse Ellipta is an anticholinergic approved in the US for the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Incruse Ellipta is approved in the EU as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Incruse contains 62.5 mcg umeclidinium delivered by the Ellipta inhaler. Full US Prescribing Information including Patient Information Leaflet are available at: us.gsk.com. For the EU Summary of Product Characteristics for Incruse, please visit http://ec.europa.eu/health/documents/community-register/index_en.htm. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Enquiries" section at the end of this document Important Safety Information for Umeclidinium (Incruse Ellipta) The following Important Safety Information is based on the Highlights section of the Prescribing Information for Incruse Ellipta. Please consult the full Prescribing Information for all the labeled safety information for Incruse Ellipta. Incruse Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to either umeclidinium, or any of the other ingredients. Incruse Ellipta should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of bronchospasm, which should be treated with an inhaled, short-acting beta2-agonist. As with other inhaled medicines, Incruse Ellipta can produce paradoxical bronchospasm, which may be life-threatening. Incruse Ellipta should be used with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately should any signs or symptoms of narrow-angle glaucoma occur. Incruse Ellipta should be used with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder neck obstruction. Instruct patients to contact a physician immediately should any signs or symptoms of urinary retention occur. The most common adverse reactions (incidence >/=2% and more common than placebo) with Incruse Ellipta (and placebo) were nasopharyngitis, 8% (7%); upper respiratory tract infection, 5% (4%); cough, 3% (2%); and arthralgia, 2% (1%). Other adverse reactions with Incruse Ellipta observed with an incidence less than 1% but more common than placebo included atrial fibrillation. Avoid co-administration of Incruse Ellipta with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects such as worsening of narrow-angle glaucoma, and worsening of urinary retention. INCRUSE™, ELLIPTA^®, ADVAIR^® and DISKUS^® are trademarks of the GlaxoSmithKline group of companies. GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013. 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GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Disk
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