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Actionable news in GSK: GLAXOSMITHKLINE PLC,

Report of foreign issuer [Rules 13a-16 and 15d-16]

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FORM 6-K

the Securities Exchange Act of 1934

For period ending October 2015

980 Great West Road, Brentford, Middlesex, TW8 9GS

(Address of principal executive offices)

Indicate by check mark whether the registrant files or

will file annual reports under cover Form 20-F or Form 40-F

Form 20-F x Form 40-F

Indicate by check mark whether the registrant by furnishing the

information contained in this Form is also thereby furnishing the

information to the Commission pursuant to Rule 12g3-2(b) under the

Securities Exchange Act of 1934.

GSK's Advair ® Diskus ® achieves primary endpoint in LABA safety study of patients with asthma

GlaxoSmithKline plc (GSK) today announced results from the 'LABA' (long acting beta 2 -agonist) safety study, AUSTRI (SAS115359). The study compared Advair ® Diskus ® , a combination of the LABA, salmeterol, and the inhaled corticosteroid (ICS), fluticasone propionate (FP), to FP monotherapy and showed that Advair (FSC) had a safety profile comparable to FP when used to treat adolescent and adult patients with asthma, assessed by the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations).

Results from the 26-week AUSTRI study, which randomised 11,751 patients across 33 countries into the study, showed FSC twice-daily (100/50mcg, 250/50mcg or 500/50mcg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100mcg, 250mcg or 500mcg), on the risk of serious asthma-related events, Hazard Ratio (HR) 1.029, (95% CI 0.638, 1.662) p=0.003. No asthma-related deaths were seen in either arm of the study. There were a total of 67 patients with serious asthma-related events across the study with 34 patients with events on FSC treatment and 33 patients with events on FP treatment. There were two asthma-related intubations in the trial, both in the FP arm; the remaining events were asthma-related hospitalisations.

AUSTRI was undertaken as a post-marketing requirement of GSK for the US Food and Drug Administration (FDA). Three other manufacturers of LABA-containing products, which are also indicated for the treatment of asthma, undertook identical studies designed to evaluate whether the addition of a LABA to an ICS increased the risk of an event...


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