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NOTE: Press Release - on 5/24 includes the following: "For medical media, outside the US only"

This information has been included for background information - (Nov 2004)

Original press release at dated 5/23

New Data Shows SPIRIVA(R) HandiHaler(R) Reduced Exacerbations and
Related Health Care Utilization in Patients With COPD
Sunday May 23, 5:09 pm ET

ORLANDO, May 23 /PRNewswire-FirstCall/ -- In investigational studies tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®) reduced exacerbations and health care
utilization in patients with Chronic Obstructive Pulmonary Disease (COPD), according to the results of a clinical study presented today at the 100th international
conference of the American Thoracic Society.(1) SPIRIVA HandiHaler was recently approved by the FDA for the long- term once-daily maintenance treatment of bronchospasm
associated with COPD, including chronic bronchitis and emphysema. ADVERTISEMENT

COPD exacerbations are episodic worsenings characterized by increased symptoms, often requiring treatment intervention and sometimes hospitalization. COPD exacerbations
and associated hospitalizations are associated with significant morbidity, mortality, health resources utilization and cost.

The main objectives of this large scale study were to evaluate the effect of treatment with tiotropium on the incidence and frequency of exacerbations and associated
hospitalizations during a six month study period. Study sites at 26 Veteran Affairs Medical Centers across the United States participated in this randomized, double-
blind, placebo controlled trial. A total of 1,829 patients were randomized to receive either tiotropium or placebo. Patients were permitted to continue using previously
prescribed respiratory medications, with the single exception of anticholinergics agents other than study drug.

Pre-specified co-primary endpoints of the study were the percentage of patients experiencing at least one exacerbation and the percentage of patients experiencing at
least one hospitalization for an exacerbation during the treatment period. Exacerbations were defined by presence of greater than or equal to 2 new of increased
respiratory symptoms (i.e. cough, sputum, wheezing, breathlessness or chest tightness) for a duration of at least 3 days and requiring treatment with antibiotics,
systemic steroids and/or hospitalization.

During the treatment period, tiotropium resulted in a significant reduction in the percentage of patients with greater than or equal to 1 exacerbation compared to placebo
(27.9% vs 32.3%; p=0.037) and a decrease in the percentage of patients who experienced greater than or equal to 1 hospitalizations (7.0% vs 9.5%; p=0.056).(1)

Additionally, tiotropium significantly reduced the number of exacerbations (0.853 vs 1.051 exacerbations per patient-year; p=0.003) (1) and number of exacerbation days
(mean: 12.61 vs 15.96 days per patient year; p<0.001)(1). Similarly, tiotropium significantly reduced the frequency of exacerbation related hospitalizations (0.177 vs
0.253 means hospitalizations per patient year, p=0.013)(1) and the number of hospitalization days (1.433 vs. 1.702, mean days per patient year, p=0.001) compared to
placebo. In addition, a reduction in the number of treatment days (antibiotic or steroids) (p<0.001)(1) and unscheduled visits to health care providers for exacerbations
(p = 0.017) were also significantly reduced with tiotropium compared to placebo.

"Guidelines state that exacerbations are one of the key targets for COPD therapy because they increase the level of disability associated with the disease. Exacerbations
are also expensive to treat as additional medication, unscheduled physician visits and hospitalization may be required," commented Professor Dennis Niewoehner of
Pulmonary Division, Veteran Affairs Medical Center and principal investigator for the study.

COPD is a slowly progressive disease of the airways that is characterized by a loss of lung function over time.(2) The signs and symptoms patients may experience are
chronic cough, excess mucus production, wheezing and shortness of breath even after mild exertion. COPD is often associated with exacerbations of these symptoms which can
account for a high proportion of health care costs associated with this disease. COPD is primarily caused by smoking.(2) There are an estimated 24 million US adults who
suffer from COPD, but only 10 million have been diagnosed. Globally, this disabling disease is the fourth leading cause of death claiming 2.74 million lives annually.(3)

About Tiotropium Bromide Inhalation Powder

Tiotropium is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. Tiotropium
is not indicated for rescue therapy and is contraindicated in patients with a history of hypersensitivity to atropine or its derivates or to any component of this
product. The most common adverse reaction was dry mouth, which was usually mild and often resolved during treatment.(4)

About Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of
the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 152 affiliates in
45 countries and more than 34,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and
marketing novel products of high therapeutic value for human and veterinary medicine.

In 2003, Boehringer Ingelheim posted net sales of US $8.37 billion (7.4 billion euro) while spending more than one fifth of net sales in its largest business segment,
Prescription Medicines, on research and development.

For more information please visit

About Pfizer Inc

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best- known consumer products. For
further information on Pfizer, please see


Source: Boehringer Ingelheim Pharmaceuticals, Inc.; Pfizer Inc
1. Niewoehner D, Rice K, Cote C, et al. Reduced COPD exacerbations and associated health care utilization with once-daily tiotropium (TIO) in the VA Medical System. Abstract presented at ATS 2004, Orlando
Florida. 21-26 May 2004.
2. National Heart, Lung, and Blood Institute. Data Fact Sheet: Chronic Obstructive Pulmonary Disease (COPD). December 2002 .
3. World Health Organization. World health report 2003.  Statistical Annex. Annex table 2: 154-159
4. Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder) Prescribing Information. Boehringer Ingelheim and Pfizer 2004.
Available at

Source: Boehringer Ingelheim Pharmaceuticals, Inc.; Pfizer Inc

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