Affiliations: National Jewish Medical and Research Center Denver, CO,
GSK Research and Development Research Triangle Park, NC
Correspondence to: Harold S. Nelson, MD, National Jewish Medical and Research Center, 1400 Jackson St, Denver, CO 80206.
To the Editor:
In a letter to the editor (June 2002),1Dr. Virchow questioned whether data from a recent article (August 2001)2were included in another published study.3 As authors of the referenced studies, we would like to confirm that the studies described were two separate studies, and data were not included from either study in the analysis of the other. In fact, the studies were conducted using different devices. The study by Nelson et al3 used the combination fluticasone/salmeterol dry powder inhaler, whereas the study by Fish et al2 used salmeterol powder as add-on therapy to the patients’ current inhaled steroid therapy.
Dr. Virchow also questions the entry requirement of > 12% reversibility in FEV1 with albuterol. A requirement for > 12%, or sometimes > 15%, reversibility is the standard in clinical asthma trials in the United States and has been required for participation in studies of inhaled corticosteroids and leukotriene pathwaymodifying agents as well as for bronchodilators. In fact, such an inclusion criteria was incorporated into a study conducted and reported by Dr. Virchow himself.4Additionally, the demonstration of > 12% reversibility is part of the definition of asthma, per the American Thoracic Society.5
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