RANDOMIZED CONTROLLED TRIAL
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Successful withdrawal of inhaled corticosteroids in childhood asthma.

OBJECTIVE: Although inhaled corticosteroids are useful and effective in the prophylaxis of childhood asthma, there is a dearth of information regarding the duration of treatment. The present study was undertaken to assess the possibility of successful withdrawal of inhaled corticosteroids in childhood asthma following good control of the disease.

METHODOLOGY: The study was carried out at the Asiri Hospital, Colombo, Sri Lanka and was a prospective observational clinical study. The participants were consecutive children with documented moderately severe and severe asthma seen over a period of 4 years from January 1990 and followed up to December 2003. Patients were allocated randomly to receive either beclomethasone dipropionate or budesonide. Initial dose of the selected drug was 300, 400 or 600 microg/day, depending on the child's age. After a period of stabilization, the dose was reduced from the starting dose to a maintenance level of 200, 300 or 400 microg/day, respectively. Once sustained control had been maintained for a period ranging from 9 to 18 months, gradual withdrawal was attempted. The dosage was reduced by 50-100 microg each time, at intervals of 3 months. Long-term follow up was maintained following withdrawal of inhaled corticosteroids. Breakthrough wheezing, acute severe attacks, hospitalization for wheezing and absence from school were used to assess the response.

RESULTS: Eighty-six children were recruited into the study. Eighty children responded well. The initial period on a high dose of corticosteroid was 8.4 months (range 4-12 months) and the average period of maintenance dosing was 11.7 months (range 9-18 months). The average time taken for withdrawal was 12.6 months (range 9-18 months). Successful withdrawal was achieved in 73 children. In this group, the mean total duration of treatment was 27.4 months (range 20-44 months). Up to December 2003, the subjects had been observed for an average period of 97.1 months (range 86-121 months) following withdrawal of inhaled corticosteroids. Of the 73 children in whom corticosteroids were withdrawn, 57 (78%) have remained well without any episodes of wheezing, and 14 (19%) have had mild episodes of wheezing that were easily controlled by bronchodilators. No patient needed hospitalization, long-term treatment or systemic corticosteroids. In two (3%) patients, it was necessary to restart inhaled corticosteroids because of troublesome recurrences.

CONCLUSION: It is possible to gradually withdraw inhaled corticosteroids in a significant proportion of asthmatic children once good control has been sustained on a maintenance dose for a considerable period.

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