המידע באדיבות מדיקונטקסט
Last Updated: 2001-07-16 17:49:19 EDT (Reuters Health)
WESTPORT, CT (Reuters Health) – Treatment with the once-daily budesonide Turbuhaler 400 mcg is safe and effective for corticosteroid-naive adults with asthma, according to a report in the June issue of the Annals of Allergy, Asthma, and Immunology.
Dr. William R. Lumry of Allergy and Asthma Research Associates, in Dallas, Texas and colleagues conducted a double-blind, placebo-controlled, multicenter study with 177 corticosteroid-naive adults randomized to placebo or once-daily budesonide Turbuhaler 400 mcg for 12 weeks.
Therapy effectiveness was measured by mean changes in forced expiratory volume in 1 second (FEV1) and morning and evening peak expiratory flow rate (PEFR); the use of breakthrough medication (albuterol); forced vital capacity (FVC); forced expiratory flow between 25% and 75% of FVC; asthma symptom scores; patient discontinuation and quality of life assessment.
The team evaluated safety based on adverse effects, physical examinations, vital signs and laboratory tests.
The study groups had comparable demographic and baseline characteristics. Patients treated with budesonide Turbuhaler had a mean percentage of predicted FEV1 at baseline of 71.9, compared with 70.6 for placebo-treated patients.
"Mean changes from baseline over the 12-week treatment period in FEV1 were significantly improved in patients receiving once-daily budesonide Turbuhaler compared with placebo (0.31 L and 0.17 L, respectively)," the investigators report. Patients treated with the budesonide Turbuhaler also had significant improvements over placebo in morning PEFR, symptoms of asthma and albuterol use.
Adverse events were mild or moderate and were similar between groups. Adverse events included respiratory infection, sinusitis headache and pharyngitis.
Ann Allergy Asthma Immunol 2001;86:627-632.
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