Chest
Original ResearchRisk Indexes for Exacerbations and Hospitalizations Due to COPD
Section snippets
Materials and Methods
The trial was performed in accordance with the recommendations in the Helsinki Declaration of 1975.24The institutional review board of all participating medical centers approved this study. All subjects gave written informed consent.
Details of the study protocol were previously described.23Briefly, all men and women receiving medical care at participating Veterans Affairs medical centers were potential study subjects. Major inclusion criteria were a clinical diagnosis of COPD, age ≥ 40 years,
Results
We randomized 1,829 subjects from among 2,498 candidates who were screened at 26 Veterans Affairs medical centers, of whom 915 were allocated to placebo and 914 to tiotropium. Study subjects were predominately white (91%) and male (99%), reflecting the composition of patients who receive medical care in Veterans Affairs medical facilities. As shown inTable 1, the average subject was elderly (mean age, 68 ± 9 years), had relatively severe COPD (FEV1, 36% predicted), received multiple respiratory
Discussion
Using a database from a large trial, we identified advancing age and low levels of lung function as major independent risk factors for both exacerbations and hospitalizations due to exacerbations. Other important independent risk factors in both models are medical events (frequencies of antibiotic and systemic corticosteroid use, unscheduled clinic/ED visits, and hospitalization, all for COPD in the prior year) that as a group might be viewed as reflecting an intrinsic susceptibility to
Participating Investigators and Study Staff
Other investigators and study staff at individual Veterans Affairs medical centers are as follows: Bay Pines: Dr. C. Cote, K. Wilson; Birmingham: Dr. A. Cooper, Jr., J. Bowden, R. Culbreth, J. Cooper; Boston: Dr. D. Gottlieb, K. Hickson; Bronx: Dr. M. Lesser, Dr. G. Schilero; Buffalo: Dr. S. Sethi, K. Eschberger; Dallas: Dr. M. Hasan, C. Lusk; Durham: Dr. S. Young, J. Smith; Gainesville: Dr. R. Gonzalez-Rothi, L. Thompson; Hampton: Dr. B. Rossheim, G. Troupe; Hines: Dr. N. Gross, A. Burns;
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The Duke Clinical Research Institute managed data for the trial.
Administrative support for all study centers was provided by the Minnesota Veterans Research Institute.
Financial support was provided by Boehringer Ingelheim and Pfizer.
Dr. Niewoehner has received grants, honoraria, or advisory fees from Boehringer-Ingelheim, Pfizer, AstraZeneca, GlaxoSmithKline, Adams Respiratory Therapeutics, and Sanofi Pasteur within the past 3 years. Dr. Rice has received honoraria from Boehringer-Ingelheim and Pfizer within the past 3 years. Dr. Sharafkhaneh has received honoraria from Boehringer-Ingelheim, Pfizer, and GlaxoSmith-Kline. Dr. Krumpe has received grants, honoraria, or advisory fees from Altana, Astra-Zeneca, Boehringer-Ingelheim, Chiron, and Pulmonix. Dr. Kesten is an employee of Boehringer-Ingelheim. Dr. Lokhnygina, Dr. Kuschner, Dr. Sarosi, and Ms. Pieper report no potential conflicts of interest.