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Tiotropium (Spiriva) Has Positive Impact On Exercise Endurance

Patients Taking Tiotropium Showed 20% Improvement
in Exercise Endurance

ATLANTA, May 2002 - The novel once-daily inhaled COPD treatment tiotropium (SPIRIVA) has been shown to improve lung volume, lung function, dyspnea (shortness of breath) and exercise endurance in patients with chronic obstructive pulmonary disease (COPD), according to data presented recently at the annual meeting of the American Thoracic Society.

In a randomized, placebo-controlled study involving 187 COPD patients, those who received tiotropium showed statistically significant improvements in lung volumes and airflow and could exercise for a longer period of time than those who took placebo. In addition to an improved ability to exercise, patients taking tiotropium reported less shortness of breath during exercise and in their daily lives.

"These results confirm the link between improvements in lung volume and the ability to exercise for longer periods of time," said Dr. Helgo Magnussen, Medical Director of the Centre of Pneumology and Thoracic Surgery in Grosshansdorf, Germany. "This translates into increased ability to participate in daily living - something we all strive to achieve for our COPD patients."

COPD is a slowly progressive airway disease that causes significant deterioration of lung function and consequently, disability and death. Smoking is the leading cause of COPD, but exposure to pollution is another known risk factor. While it is less well known than asthma, COPD is far more prevalent. According to the World Health Organization, about 600 million people suffer from COPD, although many are undiagnosed. Estimates are that by 2020, COPD will be the world's third leading cause of death.

COPD is characterized by a reduction of airflow from the lungs and an increase in air trapped inside the lungs. As more air is trapped in the lungs, the volume of the lungs increases, and air exchange is very limited. A primary goal in treating COPD patients is to increase airflow and, consequently, improve their ability to participate in daily activities.

Baseline exercise tolerance was measured on a stationary bicycle at the start of the study, with the average endurance time for all patients measuring 8.2 minutes. After three weeks of once-daily tiotropium treatment, patients could exercise for 1.1 minutes longer than those taking placebo. At six weeks, patients taking tiotropium could exercise for an additional 1.75 minutes compared to patients taking placebo, representing a 20 percent improvement.

"To reduce trapped air in the lungs is clinically important," said Dr. Denis O'Donnell, Professor of Medicine and Chair of the Division of Respiratory and Critical Care Medicine at Queen's University in Kingston, Canada. "This allows the chest wall muscles and the diaphragm to function much more effectively, translating directly into improved dyspnea and exercise performance."

In this study, tiotropium was generally well tolerated. The incidence of adverse events was similar between the two treatment groups. The only adverse events that were attributed to tiotropium were one case each of allergic reaction, dizziness and pharyngitis.

Tiotropium, which works by prolonged M3-receptor blockade, was discovered and developed by Boehringer Ingelheim and will be marketed under the name SPIRIVA in a worldwide co-promotion between Boehringer Ingelheim and Pfizer Inc. Tiotropium is approved in the Netherlands, New Zealand, and the Philippines and has successfully completed European Union regulatory review. A New Drug Application for tiotropium was submitted to the U.S. Food and Drug Administration in December 2001. Additional applications are pending worldwide.

Source: Boehringer Ingelheim News Release

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