Original articles: Asthma, rhinitis, other respiratory diseasesSalmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial☆,☆☆
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Patients
Male and female patients were eligible for the study if they were at least 12 years old and had a medical history of asthma (as defined by the American Thoracic Society6) of at least 6 months’ duration that required pharmacotherapy over the 6 months preceding the study. Patients were required to have an FEV1 between 40% to 85% of the predicted value based on European Community for Coal and Steel standards for ages 18 years and older (and readjusted for African Americans)7, 8 or Polgar standards
RESULTS
Of 527 patients screened, 356 patients were randomly assigned to treatment. The major reasons for screen failures were lack of reproducible lung function and FEV1 <40% or >85% predicted. Randomization resulted in comparable treatment groups at baseline with respect to patient demographics and pulmonary lung function (Table I). Mean adherence to treatment ranged from 93% to 100% across treatment groups. No patient was withdrawn from the study because of poor adherence to study medication. The
DISCUSSION
The results of this study demonstrated that the combination product, salmeterol 50 μg/fluticasone propionate 100 μg, offered significant clinical advantages over the administration of salmeterol or fluticasone propionate alone.
Exacerbations of asthma are a major cause of morbidity and mortality and can be classified as mild, moderate, or severe depending on the level of treatment necessary to achieve remission. In the current trial, because patients treated with inhaled corticosteroids at
Acknowledgements
We thank the following investigators for their participation in this study: T. D. Bell, MD, Missoula, Mont; B. L. Charous, MD, Milwaukee, Wis; P. Chervinsky, MD, North Dartmouth, Mass; R. Cohen, MD, Lawrenceville, Ga; J. Condemi, MD, Rochester, NY; G. Davis, MD, Burlington, Vt; D. Elkayam, MD, Bellingham, Wash; S. Galant, MD, Orange, Calif; D. Graft, MD, Minneapolis, Minn; A. Heller, MD, San Jose, Calif; G. Incaudo, MD, Chico, Calif; J. Jeppson, MD, Boise, Idaho; H. Kaiser, MD, Minneapolis,
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Supported by a grant from GlaxoWellcome Inc, Research Triangle Park, NC.
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Reprint requests: Mani Kavuru, MD, Cleveland Clinic Foundation, 9500 Euclid Ave, Desk A90, Cleveland, OH 44195.