Ending a long controversy about the effects of inhaled corticosteroids in
the treatment of people with chronic obstructive pulmonary disease (COPD), researchers
supported by the National Heart, Lung, and Blood Institute (NHLBI) today reported
that inhaled corticosteroids do not slow the progression of the disease, as
many had hoped, but they do reduce respiratory symptoms in some of these patients.
The Lung Health Study (LHS) II, which appears in the December 28, 2000 New
England Journal of Medicine, showed that patients treated with inhaled corticosteroids
experienced no significant slowing of the decline in lung function that makes
COPD ultimately deadly but did have fewer symptoms, lower health care utilization,
and some improvement in the sensitivity of the lungs to external stimuli. However,
they also had a small amount of bone loss and an increase in skin bruises compared
to the placebo group.
Said NHLBI Director Dr. Claude Lenfant, "Inhaled corticosteroids are commonly
prescribed for patients with COPD, although their effectiveness has not been
consistently shown. These findings from LHS II provide us with the full picture
of their benefits and risks.
"Smoking cessation is the only thing shown to slow the progression of COPD,
but since this is often difficult to achieve, we are investigating other ways
to prevent its progression," he added.
COPD is a term used for two closely related diseases of the respiratory system:
chronic obstructive bronchitis and emphysema. It currently affects approximately
16 million Americans and is the fourth leading cause of death in the U.S. Research
has shown that cigarette smoking is associated with 80-90 percent of COPD cases.
Chronic airway inflammation, induced by smoking, is thought to contribute
to the development of COPD. Since inhaled corticosteroids have been shown to
reduce airway inflammation in asthma, scientists had thought they might slow
disease progression in patients with COPD. LHS II shows that this is not the
LHS II involved 1,116 participants, ages 40 to 69, with mild to moderate
COPD who were either current smokers or smokers who had quit within the past
two years. Participants were randomly assigned to receive either an inhaled
corticosteroid or placebo. Lung function was evaluated every six months using
The study showed that lung function decline in the patients treated with
the inhaled corticosteroid was statistically no different from that in the placebo
group. Corticosteroid use did, however, result in 25 percent fewer respiratory
symptoms and nearly 50 percent fewer outpatient visits for respiratory problems.
However, after three years, bone density in the hip and back was lower in the
Said Dr. Robert Wise, Professor of Medicine at Johns Hopkins University and
an LHS II principal investigator, "The bone loss was not clinically important.
However, we don't know whether it would progress with prolonged use of the drug.
Physicians treating patients with COPD should weigh the benefits of inhaled
corticosteroids against the potential risks."
Participating LHS clinical centers are: Case Western Reserve University,
Cleveland, OH; Henry Ford Hospital, Detroit, MI; Johns Hopkins University, Baltimore,
MD; Mayo Foundation, Rochester, MN; Oregon Health Sciences University, Portland;
University of Alabama, Birmingham; University of California, Los Angeles; University
of Minnesota, Minneapolis; University of Pittsburgh, Pittsburgh, PA; University
of Utah, Salt Lake City; and the University of Manitoba, Winnipeg, Canada. The
Data and Coordinating Center is located in the Division of Biostatistics, School
of Public Health, University of Minnesota.
The drug used in LHS II was donated by Aventis, Inc., headquartered in Parsippany,
The NHLBI is part of the National Institutes of Health, located in Bethesda,