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September 3, 2000 

  

FLORENCE, Italy - An experimental drug could make breathing much easier for millions of people suffering from "smoker's lung," scientists say.


In tests involving 500 people who had suffered from chronic obstructive pulmonary disease for more than a decade, the drug appeared to be safer and better at improving breathing and at reducing infections and hospital visits than the best treatment currently available, researchers told scientists at the World Congress on Lung Health, which concluded Saturday.


If the inhaled drug, Spiriva, turns out to be as good as it looks right now, it could improve the quality of life for nearly half of the 600 million people with the disease, said Dr. Bartolome Celli, chief of pulmonary and critical care at St. Elizabeth's Hospital in Boston and a leading authority on the illness.


While the drug probably will not slow the deterioration of the lungs, many sufferers could see their overall well-being improve by between 30 and 50 percent, said Celli, who was not involved in the research.


"The overall effect is something that almost has never been seen," said Dr. Romain Pauwels, a professor of medicine at the University of Ghent in Belgium who conducted some of the research. "Compared to what we have now, this is far better, no matter what parameter you're measuring."


Chronic obstructive pulmonary disease, known as COPD or "smoker's lung," is an irreversible progressive illness caused by narrowing of the airways. It encompasses emphysema and chronic bronchitis. About 3 million people worldwide die from it every year, the World Health Organization estimates. About 15 million Americans have it, and about 100,000 of them die each year, according to the American Lung Association.


The new drug, which relaxes the muscles tightening the airways, is related to the commonly prescribed inhaled medication Atrovent, but targets the symptoms better and lasts longer, scientists say.


Another advantage is that the longer-acting drug, whose chemical name is tiotropium, is inhaled once a day. Atrovent, or ipratropium, has to be inhaled four times a day, and many patients simply don't take it as often as they should, Celli said.


Both drugs are made by Germany's Boehringer Ingelheim, the host for the conference session at which two studies comparing the drugs were presented.


"There is no doubt it is a significant step forward," said Dr. Paul Jones, a professor of respiratory medicine at St. George's Hospital Medical School in London who did not conduct any of the research but designed the well-being standards measured in the studies.


"Tiotropium caused an improvement in their health and that was maintained with very little evidence of deterioration over the next year," he said. "That's a really exciting, and an unexpected, finding. Those taking the short-acting drug were clearly getting worse after the first three months of treatment."


Even with the best treatment available, life is quite hard for the type of patients in the studies - those who have moderate or COPD, Jones said.


"They often have to walk more slowly than someone of their own age. A lot of them have to stop when they are getting washed or dressed. A lot of them can't leave their house to do their shopping because of breathlessness," he said


"In this study, 20 percent of the patients were housebound because of their breathlessness, and that is pretty typical for the type of patient in whom we'd be using this class of drug," Jones said.


Those on the drug experienced improvements such as being able to walk as fast as their spouses, washing and dressing without having to take a break to catch their breath and bending over without breathlessness, he said.


"That's a very important thing," Jones said. "People laugh and snigger about getting breathless bending over, but bending over is very important for many activities - picking up things, putting on your socks - and it's a major problem for patients with COPD. Most of them complain about it."


The company said it plans to apply for European approval for the drug by the end of this year and for U.S. approval a year later. If accepted, it could be available by 2002.



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