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START Trial
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Clinical Question:
Is budesonide 200 mug via turbohaler is safe and well tolerated in children
with recent-onset mild persistent asthma?
Bottom Line:
The addition of once-daily inhaled budesonide 200 mug via Turbuhaler(TM) to
usual care is safe and well tolerated in children with recent-onset mild
persistent asthma.
Reference:
Safety and tolerability of inhaled budesonide in children in the Steroid
Treatment As Regular Therapy in early asthma (START) trial.Silverman M,
Sheffer AL, Diaz PV, Lindberg B.Pediatr Allergy Immunol. 2006 May;17 Suppl
17:14-20. |
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Study Design:
Randomized Controlled Trial (double blind)
Synopsis:
The safety and tolerability of asthma medications are still a concern to
many asthma patients receiving long-term treatment. Therefore, more safety
data from long-term, controlled trials are needed. The aim of this study was
to evaluate the safety and tolerability of long-term treatment with
once-daily budesonide in children aged 5-10 yrs with mild persistent asthma
of recent onset in the inhaled Steroid Treatment As Regular Therapy in early
asthma (START) study. Children aged 5-10 yrs with early asthma were
randomized to double-blind treatment with budesonide 200 mug or placebo once
daily via Turbuhaler(TM) in addition to usual asthma therapy, for 3 yrs.
Adverse events were recorded from both spontaneous reports and responses to
standard questions, and asthma-related events and asthma control were
recorded between visits and subsequently graded by the blinded
investigators. Of the study population of 1981 children (1004 budesonide and
977 usual care), 81% (812 of 1004) in the budesonide group and 82% (797 of
977) in the usual care group experienced a total of 6414 events listed by
preferred term (3209 budesonide plus usual care and 3205 placebo plus usual
care). The most commonly reported events included respiratory infection,
pharyngitis, rhinitis, viral infection and bronchitis, and there were no
clinically relevant differences in incidence between treatments. There were
no reports of tuberculosis or aspergillosis, and no evidence of increased
risk of systemic or ocular adverse events with budesonide relative to
placebo. There were 106 serious adverse events in the budesonide group and
128 with usual care. The most frequent, aggravated asthma, was more common
with usual care than with budesonide. There were no deaths among children
participating in START. |
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