Improved Efficiency of Pulmonary Delivery of Budesonide with Respimat® Soft Mist™ Inhaler Compared with Turbohaler or pMDI

Abstract

with Respimat® Soft MistTM Inhaler Compared with Turbohaler or pMDI C. C. Wood1, B. van Toor2, V. Hasselbarth2, H. Stammer2, H. Voss2; 1Respiratory and Immunology Clinical Operations, Boehringer-Ingelheim Pharmaceuticals Inc, Ridgefield, CT, 2Human Pharmacology, Boehringer Ingelheim Pharma KG, Ingelheim, GERMANY. RATIONALE: More efficient delivery of an inhaled steroid to the pulmonary target organ allows for a lower nominal, nevertheless comparable lung dose and possible reduction in systemic steroid side effects. METHODS: Seventy-one normal male volunteers (20 to 49 years) in a 21 day placebo controlled trial received budesonide via Respimat® SMI (0.2, 0.4 or 0.6 mg BID), Turbohaler (0.8 mg BID) or beclomethasonepMDI (1.0 mg BID). Plasma budesonide time course concentrations were measured along with standard safety assessments. 24-hour urinary free cortisol, serum cortisol, osteocalcin levels and a short ACTH stimulation test (0.25 mg tetrosactrin) were done. RESULTS: Pharmacokinetic and pharmacodynamic results demonstrated that Respimat® SMI delivers the substance more efficiently to the lung than Turbohaler. AUC (NG*H/ML) for Respimat® SMI was dose-linear: 0.747, 1.458 and 2.105 for the 0.2, 0.4 and 0.6 mg BID doses. Turbohaler (0.8 mg BID) AUC was 2.104. No difference in suppression of 24-hour urinary free cortisol excretion was observed between the highest dose of budesonide delivered via Respimat SMI and the Turbohaler or beclomethasone-pMDI doses. The two lower doses of budesonide delivered via Respimat SMI had less of an effect on 24-hour urinary excretion, and no significant effect on plasma cortisol or osteocalcin levels. No active treatment had any effect on serum calcium, inorganic phosphorus or ostase compared with placebo nor affected the ACTH stimulation test. S82 Abstracts J ALLERGY CLIN IMMUNOL FEBRUARY 2006 S A T U R D A Y 320 Modern Technology Making Immunotherapy Safer R. G. Houser, J. B. Hunter, S. Shaeffer, L. H. Fisher, T. J. Craig; Allergy/ Immunology, Penn State Hershey Medical Center, Hershey, PA. RATIONALE: A recent trend in allergy has been standardization to decrease the risk associated with skin testing and immunotherapy. Electronic programs further help in decreasing errors by practice standardization, charting and obliged queries. METHODS: Computerized immunotherapy with personalized scan cards was instituted in the spring of 2005. After the patient’s card is scanned, the immunotherapy records are visualized along with the patient’s picture. A printed label on each vial allows the scanner to verify that the vial is the appropriate strength for that specific individual. The electronic program shows the previous dose and how long ago it was given. It then prompts for the next scheduled dose to be given. All adverse reactions from previous injections are highlighted in red. After the injection is given, a builtin timer monitors the amount of time the patient was observed before charting the results. The program prompts for peak flow and designates peak flow values to hold immunotherapy. RESULTS: On past review the literature of immunotherapy, most errors are clerical due to inappropriate doses or to patients receiving incorrect extracts. Each error is addressed with the electronic immunotherapy program, therefore decreasing the risk associated with immunotherapy. Electronic immunotherapy has been effective in our office on improving quality of care. CONCLUSIONS: With the help of an electronic program and using the “Five Rights” (right medication, right dose, right time, right route and right patient) immunotherapy administration is now safer. Funding: Hershey Medical Center