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Budesonide Safe, Effective Treatment for Asthma

Budesonide inhalation powder is a safe and effective treatment for adults and children with mild to severe asthma, according to a recent study.

Corticosteroids are the most effective anti-inflammatory drugs for the treatment of persistent asthma in adults and children. However, long-term use can lead to hypothalamic-pituitary-adrenal (HPA) axis suppression, skin changes, cataracts, glaucoma, osteoporosis, and growth suppression.

Inhaled corticosteroids are, however, able to avoid the systemic adverse effects through direct delivery to the airways.

David G. Tinkelman, M.D., from the National Jewish Medical and Research Center, Denver, Colorado, United States, and US colleagues evaluated the efficacy and safety of budesonide inhalation powder in patients with mild to severe asthma.

The open-label study included 1,133 patients between the ages of 6 and 70 years old that were given 100-800 microg b.i.d of budesonide (Pulmicort Turbuhaler®-AstraZeneca LP) for 52 weeks. Patients had participated in a double-blind study just before entering this study, of which 382 adults and 356 children had received inhaled corticosteroids and 144 adults received oral corticosteroids and 249 adults had not received corticosteroids.

Pulmonary function was assessed by measuring the forced expiratory volume in 1 sec (FEV1) before double-blind study, at start of open-label study, and 6, 12, 25, 38, and 52 weeks after start of budesonide treatment.

Before the double blind study, the mean FEV1 for this entire group of patients was 68.2% of that measured for normal controls. After the corticosteroid study this increased to 74.4%.

After 52 weeks of taking budesonide, the mean increased even further to 81.3% of normal volume. Improvement was seen at 6 weeks and maintained throughout the rest of the study. Patients who had not received prior inhaled corticosteroid therapy showed the greatest improvement in FEV1.

budesonide treatment also allowed patients to remain oral corticosteroid-free. Specifically, of 64 patients given oral corticosteroids in the double blind study, 91% remained free of their corticosteroid use during the budesonide study.

budesonide appeared to be well-tolerated by the participants. budesonide-related adverse events occurred in 12% of patients and included oral moniliasis, pharyngitis, and voice alterations.

Dr. Tinkelman concludes that "budesonide maintained the improved pulmonary function and decreased oral corticosteroid use observed during previous double-blind treatment and was well tolerated." This supports the "long-term use [of budesonide] in adults and children with mild to severe persistent asthma."

This study was supported by a grant from Astra-Zeneca LP, Wilmington, Delaware, United States.
J Asthma 2003;40:3:225-236. "Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma"

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