Is there a dose-response relationship for Pulmicort Respules?
In patients with stable asthma inhaled corticosteroids, irrespective of delivery system, have a flat dose-response curve. A factor of four is usually required in clinical studies to demonstrate a significant difference between doses. Depending on the variability in lung deposition when using nebulizers it has been very hard to establish dose-response relationships for Pulmicort Respules. Several studies have been performed using more than one dose level and the results have been compared with placebo (1). Usually all doses, 0.25 mg once or twice daily, 0.5 mg once or twice daily, and 1 to 4 mg twice daily have been better than placebo regarding symptom control and changes in lung function. However, statistically significant differences between doses have usually not been found, and not in a consistent manner. This is illustrated in a study in 102 children with stable asthma (age 5-47 months) who were treated with Pulmicort Respules, 0.25 or 1 mg twice daily, for 18 weeks (2). When symp