Project Details
Description
Chronic obstructive pulmonary disease (COPD) affects 10 million Americans
and is increasing in prevalence and as a cause of death and disability.
Although the disease can be identified in the asymptomatic phase, little
is known about interventions to arrest the accelerated decline in lung
funCtion, which eventually leads to disability. Inflammation of the
peripheral airways is a histologic hallmark of this disorder, and it is
thought that this inflammation leads to the clinical manifestations of the
disease--alveolar wall destruction (emphysema) and bronchial
hyperreactivity (bronchospasm). It is not known whether inhaled anti-
inflammatory agents, in particular, inhaled corticosteroids, can alter the
natural history of this disease or reduce morbidity and mortality. The
present study is designed to determine, in a multicenter placebo-
controlled clinical trial, whether the use of an inhaled corticosteroid
(triamcinolone acetonide 400 micrograms twice daily) can alter the
accelerated decline in lung function. Ten clinical Centers throughout
North America will enroll 1,540 participants with mild to moderate COPD
who have previously had 5 years of monitoring of lung function and
bronchial reactivity in the Lung Health Study. Half of the participants
will be assigned active drug, and half an identical-appearing placebo.
All smoking participants who express interest will receive smoking
cessation counseling. Spirometry will be measured every six months for up
to 4-1/2 years to determine whether the treatment will alter the decline
in lung function. In addition, bronchial reactivity, respiratory symptoms,
morbidity, mortality, and quality of life will be measured to determine
whether this intervention improves health status. Secondary objectives of
the study will be to determine whether this intervention has adverse
effects; to measure the patterns of adherence with the drug; and to
determine whether there are certain subgroups of people who benefit or who
are susceptible to adverse effects.
and is increasing in prevalence and as a cause of death and disability.
Although the disease can be identified in the asymptomatic phase, little
is known about interventions to arrest the accelerated decline in lung
funCtion, which eventually leads to disability. Inflammation of the
peripheral airways is a histologic hallmark of this disorder, and it is
thought that this inflammation leads to the clinical manifestations of the
disease--alveolar wall destruction (emphysema) and bronchial
hyperreactivity (bronchospasm). It is not known whether inhaled anti-
inflammatory agents, in particular, inhaled corticosteroids, can alter the
natural history of this disease or reduce morbidity and mortality. The
present study is designed to determine, in a multicenter placebo-
controlled clinical trial, whether the use of an inhaled corticosteroid
(triamcinolone acetonide 400 micrograms twice daily) can alter the
accelerated decline in lung function. Ten clinical Centers throughout
North America will enroll 1,540 participants with mild to moderate COPD
who have previously had 5 years of monitoring of lung function and
bronchial reactivity in the Lung Health Study. Half of the participants
will be assigned active drug, and half an identical-appearing placebo.
All smoking participants who express interest will receive smoking
cessation counseling. Spirometry will be measured every six months for up
to 4-1/2 years to determine whether the treatment will alter the decline
in lung function. In addition, bronchial reactivity, respiratory symptoms,
morbidity, mortality, and quality of life will be measured to determine
whether this intervention improves health status. Secondary objectives of
the study will be to determine whether this intervention has adverse
effects; to measure the patterns of adherence with the drug; and to
determine whether there are certain subgroups of people who benefit or who
are susceptible to adverse effects.
| Status | Finished |
|---|---|
| Effective start/end date | 9/10/93 → 8/31/99 |
Funding
- National Institutes of Health: $200,972.00
- National Institutes of Health: $340,029.00
- National Institutes of Health: $367,486.00
ASJC
- Medicine(all)
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