Tiotropium effective for COPD — study

BERLIN, Germany — Tiotropium was shown effective in treating patients with chronic obstructive pulmonary disease (COPD), according to data from a long-term clinical trial presented here at the annual meeting of the European Respiratory Society.

Tiotropium, a once-daily inhaled anticholinergic, was found superior to the long-acting beta agonist salmeterol in several key aspects.

A six-month study involving 623 COPD patients showed that patients receiving tiotropium had significantly improved lung-function measurements compared to patients receiving either placebo or salmeterol.

Moreover, patients receiving tiotropium showed significant improvements in breathlessness and health-related quality of life versus placebo.

According to the data, patients who received either tiotropium or salmeterol showed statistically significant improvement in pre- and post-dose FEV1, the volume of air measured during forced exhalation, versus patients who took placebo.

Tiotropium was shown to be significantly superior to salmeterol in lung function, as measured by FEV1, during the course of the study. There was no evidence of a loss of effectiveness of tiotropium during the course of the duty.

Shortness of breath

Shortness of breath, known as dyspnea, represents the most disabling respiratory symptom for patients with COPD. In the study, patients receiving tiotropium reported a statistically significant improvement in shortness of breath versus patients who received placebo. There was no significant improvement in shortness of breath in patients treated with salmeterol versus placebo.

At the end of the study, tiotropium patients also reported statistically significant improvements in health-related quality of life as measured by the St. George‘s Respiratory Questionnaire, versus patients who took placebo. Using the same measure, the effects of salmeterol were not significantly different from placebo.

In this study, the most common side-effect associated with tiotropium was dry mouth. The proportion of patients who reported side-effects was similar in all three treatment groups.

However, the number of patients who withdrew from the study due to side-effects was lower in the tiotropium group than in either the salmeterol group or the placebo group.

"These data show that we were able to provide COPD patients in this trial with positive and sustained therapeutic benefit," says Dr. James Donohue, professor of medicine at the University of North Carolina in Chapel Hill.

Progressive disease

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 and genetic predisposition are other known risk factors.

While it is less well-known than asthma, COPD is, in fact, more prevalent. According to the World Health Organization, about 600 million people suffer from COPD, although many are undiagnosed.

"A nihilistic attitude toward COPD has developed among some healthcare workers due to the limited success in prevention, the perception that COPD is largely self-inflicted and disappointment with the available treatment options," says Dr. Romain Pauwels, professor of medicine at the University of Ghent and head of the GOLD Scientific Committee. "The results we have seen to date on Spiriva could help change this attitude."

Triotropium, discovered and developed by Boehringer Ingelheim, is a novel compound that works through prolonging M3-receptor antagonism. When approved, tiotropium will be the first once-daily inhaled treatment for COPD.

Global agreement

Earlier this year, Boehringer Ingelheim and Pfizer Inc. announced that they have entered into a long-term worldwide agreement to co-promote tiotropium.

Spiriva has been filed for marketing approval in Europe and several other countries, where it could be available as early as mid-2002. A new drug application for Spiriva is expected to be filed with the US Food and Drug Administration in the near future.

The Boehringer Ingelheim group of companies, headquartered in Ingelheim, Germany, is one of the 20 leading pharmaceutical corporations in the world.

Boehringer Ingelheim, which has some 140 affiliated companies worldwide, focuses on human pharmaceuticals and animal health.

The human pharmaceutical business, which accounts for 95 percent of sales, is comprised of prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers.

Research and development, production and distribution facilities are located around the globe. In 2000, Boehringer Ingelheim spent almost one billion euros on R&D, equivalent to 16 percent of net sales.

Pfizer Inc. discovers, develops, manufacturers and markets leading prescription medicines for humans and animals, and many of the world’s best-known consumer products.