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* No increased risk seen with Boehringer's Spiriva Respimat
* New study contrasts with safety concerns raised in 2011
LONDON, Sept 8 (Reuters) - A major study on the safety of amist inhaler used to treat chronic lung disease has found itdoes not increase the risk of patients dying early, in contrastto an earlier analysis published two years ago.
The reassuring result with a formulation of BoehringerIngelheim's Spiriva delivered through its new Respimat device isgood news for the German drugmaker and potentially for othersdeveloping rival products containing so-called LAMA drugs.
Data from the 17,135-patient study, comparing the safety andefficacy of Spiriva Respimat against a formulation of the druggiven via the older HandiHaler device, were unveiled at theEuropean Respiratory Society congress in Barcelona on Sunday.
Competitors in the field include GlaxoSmithKline,whose experimental product Anoro combining a LAMA drug with adifferent kind of treatment called a LABA will be assessed by aU.S. Food and Drug Administration advisory panel on Sept. 10.
The encouraging safety message on Spiriva Respimat may lowerthe regulatory hurdle for such new LAMA-containing products,industry analysts believe.
Several drugmakers are betting that LABA/LAMA inhalers willbecome the first choice for chronic obstructive pulmonarydisease (COPD), which causes debilitating breathlessness andaffects more than 200 million people worldwide.
Other companies working on long-acting beta-2-agonist (LABA)and long-acting muscarinic antagonist (LAMA) combinationsinclude Novartis, which has an alliance with Vectura ; AstraZeneca, following its recent acquisitionof Pearl Therapeutics; and a partnership of Almirall and Forest Laboratories.
Boehringer itself also has a LABA/LAMA drug in development.
Current market-leading drugs for COPD include Spiriva andGSK's Advair.
Spiriva has been on the market since 2002 but concerns aboutits safety were aroused in 2011 when a study based on a pooledanalysis of previous trials suggested patients taking it via theRespimat device increased their risk of dying by 52 percentcompared to those on placebo.
Boehringer and its marketing partner Pfizer disputedthe findings at the time.
The new three-year clinical trial found Respimat was just assafe as the older HandiHaler inhaler and that COPD patientsenjoyed a median 756 days without a sustained worsening ofsymptoms against 719 days among those using the HandiHaler. Thenew trial did not include a placebo group.
Boehringer hopes the new company-sponsored trial - one ofthe biggest to date in COPD - will draw a line under the safetyquestion and reinforce the benefits of all Spiriva formulations.Global sales of Spiriva last year were $4.6 billion.
The outcome is also important for Boehringer's futureambitions in developing new medicines, including its LABA/LAMAproduct, since these also rely on the Respimat device.
The new study, which was sponsored by Boehringer, waspublished simultaneously in the New England Journal of Medicine.
