Chest
Clinical InvestigationsASTHMATherapeutic Effect of Zafirlukast as Monotherapy in Steroid-Naive Patients With Severe Persistent Asthma
Section snippets
Trial Design
This analysis evaluated a subset of 261 men and women who received treatment with a 20-mg twice daily (bid) dose of zafirlukast (n = 149) or placebo (n = 112) in four randomized, double-blind, placebo-controlled, 13-week trials with similar study designs, entry criteria, and clinical assessments. All of the trials had three periods, including a 1-week screening, a 2- to 3-week, single-blind, placebo run-in, and 13 weeks of double-blind treatment. All four trials were conducted under the
Results
Two hundred sixty-one patients with severe persistent asthma (zafirlukast, n = 149; placebo, n = 112) were included in the subgroup analyses. More than half of this patient population consisted of men who were > 30 years of age and who had moderate pulmonary obstruction as demonstrated by an FEV1/FVC ratio of < 0.70 (Table 2). Baseline asthma characteristics were similar between the zafirlukast and placebo groups. On average, patients had a percent predicted FEV1 of approximately 53%, between
Discussion
This retrospective analysis in steroid-naive patients with severe persistent asthma was prompted by the finding that 261 patients from the zafirlukast clinical trial program who were diagnosed as having mild-to-moderate asthma on the basis of their treatment history met the NAEPP classification for severe persistent asthma. Although the ideal approach to therapy for these patients involves treatment with an optimized dose of inhaled corticosteroid therapy or combination therapy with inhaled
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Cited by (0)
For related editorial see page 313.
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Dr. Kemp is a consultant to Zeneca Pharmaceuticals anda participating investigator in zafirlukast clinical trials. Financial support for this study was provided by Zeneca Pharmaceuticals, Wilmington, DE.