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 multi-center placebo- controlled clinical trial whether the use of an inhaled corticosteroid (triamcinolone acetonide 400 mug 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 and one half 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 the 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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL050286-06
Application #
2771349
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1993-09-27
Project End
1999-08-31
Budget Start
1998-09-01
Budget End
1999-08-31
Support Year
6
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218