Monday, May 26, 2014

COPD: First Phase III Data Show Lung Function Benefits of Tiotropium + Olodaterol Fixed-Dose Combination go Beyond Tiotropium (Spiriva®) Alone

SAN DIEGO. - Thursday, May 22nd 2014 [ME NewsWire]

ATS 2014

   Results from VIVACITO™ study showed significant improvement in lung function (FEV1*) using

fixed-dose combination of tiotropium and olodaterol (tiotropium + olodaterol FDC†) in patients with  

 COPD‡, compared to monotherapies or placebo1
   VIVACITO™ is the first study presented from the >8,000 patient TOviTO™ Phase III clinical trial

programme for tiotropium + olodaterol FDC

    Further tiotropium + olodaterol FDC data on patient outcomes such as quality of life are due to

report later this year

(BUSINESS WIRE) For media outside of the US, the UK & Canada only

Boehringer Ingelheim today announced the first Phase III data for the once-daily fixed-dose

combination of tiotropium and olodaterol. Results from the Phase III VIVACITO™ study show that

once-daily tiotropium + olodaterol FDC improved lung function (FEV1*) of COPD patients to levels

significantly above those achieved with tiotropium or olodaterol monotherapies, or with placebo.

The 6-week trial with an incomplete crossover design was conducted in patients with moderate to

severe COPD. The results were presented at the American Thoracic Society (ATS) 2014 International

Congress in San Diego. Further data from the Phase III programme for tiotropium + olodaterol FDC

are due to report later this year.

They are expected to further show the efficacy and safety of the tiotropium + olodaterol FDC and

how its benefits in lung function translate into meaningful benefits to patients in their daily lives.

“Many COPD patients remain symptomatic despite current standard care and therefore are limited in

their daily activities, like meeting friends or doing outdoor activities. New, innovative treatments are

needed to help improve patients’ lung function and their quality of life," said Klaus F. Rabe,

Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of

Pneumology at Clinic Grosshansdorf, Germany. “The increase of more than 200 ml in trough FEV1

seen in the VIVACITO™ study with tiotropium + olodaterol FDC compared to placebo is significant.

A few years ago we would simply not have thought this level of improvement would be possible.”

Once-daily tiotropium + olodaterol FDC is an investigational treatment that contains the well-

established once-daily LAMA§ tiotropium (Spiriva®) combined with olodaterol (Striverdi®), the

new once-daily and fast-acting LABA** delivered by the Respimat® SoftMist™ Inhaler. Respimat®

is an innovative inhaler delivering a unique slow-moving SoftMist™ that allows gentle inhalation –

making it easy for patients to take their therapy.

The VIVACITO™ data show that the tiotropium + olodaterol FDC demonstrated clear and consistent

improvements in lung function (FEV1*) over 24 hours compared with tiotropium or olodaterol

monotherapies, and placebo. In the study, tiotropium + olodaterol FDC was shown to have a safety

profile similar to tiotropium.

The results from VIVACITO™ are the first Phase III data for tiotropium + olodaterol FDC presented

from the TOviTO™ programme, one of the largest Phase III clinical trial programmes ever conducted

in COPD. In addition to evaluating the effects of the tiotropium + olodaterol FDC on lung function,

the TOviTO™ programme is also focused on the evaluation of other important clinical outcomes

related to the daily life of patients with COPD.

Results from the pivotal 52-week Phase III TONADO™ 1&2 trials, investigating the effect of

tiotropium + olodaterol FDC on lung function and quality of life in patients with COPD, are due to

report later in 2014.

These data will form a major part of Boehringer Ingelheim’s submission to regulatory authorities to

support the registration of tiotropium + olodaterol FDC in COPD.

* FEV1 is the maximum volume of air that can be forcibly expired in 1st second, following maximal

inspiration and is an important indicator of lung function

†Tiotropium + olodaterol FDC is an investigational treatment. It has not been approved for clinical

use. Its safety and efficacy have not yet been fully established

‡Chronic obstructive pulmonary disease

§Long-acting muscarinic antagonist

**Long-acting beta2-agonist

For more detailed information please follow the links below:

    Tiotropium + olodaterol FDC backgrounder: click here
    VIVACITO™ clinical trial backgrounder: click here
    TOviTO™ clinical trial programme backgrounder: click here
    Notes to editors and references: click here


Boehringer Ingelheim

Corporate Communications

Media + PR

Kristin Jakobs

Phone: +49 (6132) 77-14 45 53

Fax: +49 (6132) 77-66 01


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