Key results from new tiotropium studies in COPD and asthmato be presented at ERS 2012

• First Phase III exacerbation and lung function data for tiotropium via the Respimat® inhaler in asthma ^*
• New Phase II data on combination of tiotropium and olodaterol administered by Respimat® in COPD ^†

Ingelheim, Germany, 27th August, 2012 – New data to be presented at the Annual Congress of the European Respiratory Society (ERS 2012), in Vienna, Austria, will shed light on the current and potential future role of tiotropium, the first once-daily long-acting inhaled anticholinergic for patients with Chronic Obstructive Pulmonary Disease (COPD).

Highlights from the accepted abstracts include the first Phase III exacerbation and lung function data for Boehringer Ingelheim’s and Pfizer’s tiotropium in asthma. These results derive from two replicate studies evaluating the efficacy of once-daily tiotropium administered by the Respimat® Soft Mist^TM Inhaler (SMI) in patients with severe asthma who remain symptomatic on at least ICS^‡ /LABA^§ . The data are relevant since a significant proportion of patients with asthma remain symptomatic despite current treatment options and may have asthma exacerbations.¹

A further presentation will focus on results from a Phase II study that investigates the potential of a future fixed-dose combination (FDC) of tiotropium and Boehringer Ingelheim’s once-daily LABA olodaterol in patients with COPD. This Phase II trial was looking at the impact of different doses of tiotropium and olodaterol as a free combination on lung function, both administered individually by the Respimat® SMI.

Boehringer Ingelheim has already started to evaluate the tiotropium and olodaterol FDC in the TOviTO^TM Phase III clinical trial programme.

In addition, a new analysis of the four year UPLIFT^TM data will be presented. This study evaluated the effect of tiotropium (18 µg via HandiHaler®) in low risk patients based on the newly defined patient groups in the updated report of the Global Initiative for Chronic Obstructive Lung Disease (GOLD). It will further add to the wealth of data for tiotropium in COPD, which has now been investigated in 175 clinical trials in COPD.

The ERS congress is the largest respiratory meeting in the World, with attendance from more than 100 countries.² All tiotropium abstracts can be accessed through the ERS website, http://www.erscongress2012.org/.

^*Tiotropium is not licensed for the treatment of asthma

^† The combination of tiotropium and olodaterol is not licensed for the treatment of COPD

^‡Inhaled corticosteroids

^§Long-acting beta₂-agonists