OBJECTIVE: DESIGN AND SETTING: Treatment protocol study at a tertiary pulmonary care centre at a children's hospital. PATIENTS: Eight children with severe persistent steroid dependent asthma (mean age 11.6 years [range 10 to 13 years], mean duration of asthma 8.37 years [range three to 11 years]) were enrolled in the study. MEASUREMENTS: Inhaled FP 880 mug/day (two puffs of 220 mug/puff, two times a day) was added to the children's asthma treatment, and attempts were made to reduce the dose of oral steroids by 20% every two weeks over a six-month period. After this six-month period, in the patients responding to inhaled FP, the dose of inhaled FP was reduced to 440 mug/day (two puffs of 110 mug/puff, two times a day) for the next six months. The mean percentage predicted values for forced expiratory volume in 1 s (FEV(1)) and maximal mid-expiratory flow rate (FEF(25%-75%)) were compared during the first month, at two to six months, and at seven to 12 month intervals before and after starting FP. The number of asthma exacerbations, emergency room visits, hospital admissions and number of school days lost were also compared. RESULTS: Within three months of starting inhaled FP, the mean alternate-day oral steroid dose decreased from 38 mg to 2.5 mg. In addition, six patients (66%) were able to discontinue the use of oral steroids. There was significant improvement in the number of mean emergency room visits per patient (P=0.016), mean asthma exacerbations per patient (P=0.016), mean hospital admissions per patient (P=0.016) and mean number of school days lost per patient (P=0.004) while patients were receiving high dose inhaled FP compared with oral steroids. There was no deterioration of any of the above mentioned parameters during the six month period when the dose of inhaled FP was reduced. The mean FEV(1) and FEF(25%-75%) during the two- to six-month and seven- to 12-month periods showed significant improvement, while the patients were receiving FP compared with oral steroids (P<0.05 for both parameters for both time periods). CONCLUSIONS: High dose inhaled FP 880 mug/day has an important oral steroid-sparing effect. After oral steroids are tapered, patients maintain adequate control of asthma with low dose inhaled FP. These findings suggest that FP may control asthma better than oral steroids.
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