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Clinical InvestigationsBronchodilatorsSalmeterol Plus Theophylline Combination Therapy in the Treatment of COPD
Section snippets
Patient Selection
Male and female patients ≥ 45 years old with COPD due to chronic bronchitis or emphysema were recruited to participate from 74 outpatient clinics in the United States. Screening entry criteria required a smoking history of at least 20 pack-years, FEV1 ≥ 0.70 L and ≤ 65% of predicted normal based on standards of Crapo et al,19 and an FEV1/FVC ratio of ≤ 70%. Patients with an FEV1 < 0.70 L were eligible if their percent predicted FEV1 was at least 40% of predicted normal. Patients with a history
Disposition and Demographics
A significant percentage of screened patients (242 of 1,185; 20%) were withdrawn during the open-label theophylline titration period (Fig 1) . Of these, 107 of 242 patients (44%) were withdrawn due to adverse events related to theophylline, and an additional 30 of 242 patient (12%) failed to achieve the target theophylline concentration within the allotted time period. Once randomization to study treatment was complete, 86% (803 of 938) of the patients completed the study. The most common
Discussion
To our knowledge, this is the first study that has compared the efficacy and safety of combination treatment with salmeterol plus theophylline vs either agent alone in patients with COPD. All treatment groups significantly improved compared to baseline in a variety of efficacy measures, showing that both salmeterol and theophylline as single agents provide benefit to patients with COPD. However, combination treatment with salmeterol plus theophylline consistently provided significantly greater
ACKNOWLEDGMENT
We thank Amy Schaberg for assisting with the preparation of this article.
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Presented in abstract form at the 2000 American Thoracic Society Meeting, Toronto, Canada, May 8, 2000.
This study was supported by a grant from Glaxo Wellcome Inc, Research Triangle Park, NC.
Dr. Mahler is a consultant to Glaxo Wellcome Inc.