Comparative efficacy and safety of albuterol sulfate spiros inhaler and albuterol metered-dose inhaler in asthma

Study objective: To compare the long-term efficacy and safety of albuterol administration using a Spires Inhalation System (Dura Pharmaceuticals; San Diego, CA) dry powder inhaler (DPI) and albuterol (Ventolin; Glare Wellcome ; Research Triangle Park, NC) administration using a metered-dose inhaler ( MDI) in patients with asthma. Materials and methods: This was a phase III, 12-week, randomized, double-bl ind, double-dummy, placebo-controlled, parallel-group, multicenter study of 283 adolescent and adult patients with mild to moderate asthma. The patien ts were randomized into one of three treatment groups: the Spires group, wh o were given 108 mu g/actuation of albuterol sulfate equivalent to 90 mu g of albuterol base; the MDI group, who were given 90 mu g/actuation of albut erol; and the placebo group. Results: Over the length of the study, the Spires and MDI groups were compa rable in all FEV1 parameters. Both active treatment groups were superior to the placebo group for each FEV1 parameter at all visits. With the exceptio n of differences at treatment week 0 for the maximum percent change in the FEV1, the duration of effect, and the area under the curve at baseline, the re were no statistically significant differences between the Spiros and MDI groups for any FEV1 parameters, Using a repeated-measures analysis, the FE V1 parameters at week 0 for the Spires group were not statistically signifi cantly different from the parameters at weeks 4, 8, and 12. The same analys is effect at week 0 for the MDI group was greater for maximum percent chang e in the FEV1 from baseline (weeks 4, 8, and 12) and duration of effect. Ad verse events and changes in clinical laboratory values, vital signs, ECG re sults, and physical examinations were reported with similar incidence in ea ch of the three treatment groups. Conclusion: Both active treatments were superior to the placebo treatment. The Spires DPI was well tolerated and was as effective as the albuterol MDI in treating patients with moderate asthma.