{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T20:56:56Z","timestamp":1761512216349},"reference-count":30,"publisher":"Wiley","issue":"s17","license":[{"start":{"date-parts":[[2006,3,28]],"date-time":"2006-03-28T00:00:00Z","timestamp":1143504000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Allergy Immunology"],"published-print":{"date-parts":[[2006,5]]},"abstract":"<jats:p>The safety and tolerability of asthma medications are still a concern to many asthma patients receiving long\u2010term treatment. Therefore, more safety data from long\u2010term, controlled trials are needed. The aim of this study was to evaluate the safety and tolerability of long\u2010term treatment with once\u2010daily budesonide in children aged 5\u201310\u2003yrs with mild persistent asthma of recent onset in the inhaled Steroid Treatment As Regular Therapy in early asthma (START) study. Children aged 5\u201310\u2003yrs with early asthma were randomized to double\u2010blind treatment with budesonide 200\u2003<jats:italic>\u03bc<\/jats:italic>g or placebo once daily via Turbuhaler<jats:sup>TM<\/jats:sup> in addition to usual asthma therapy, for 3\u2003yrs. Adverse events were recorded from both spontaneous reports and responses to standard questions, and asthma\u2010related 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. In conclusion, the addition of once\u2010daily inhaled budesonide 200\u2003<jats:italic>\u03bc<\/jats:italic>g via Turbuhaler<jats:sup>TM<\/jats:sup> to usual care is safe and well tolerated in children with recent\u2010onset mild persistent asthma.<\/jats:p>","DOI":"10.1111\/j.1600-5562.2006.00380.x","type":"journal-article","created":{"date-parts":[[2006,3,28]],"date-time":"2006-03-28T15:09:09Z","timestamp":1143558549000},"page":"14-20","source":"Crossref","is-referenced-by-count":17,"title":["Safety and tolerability of inhaled budesonide in children in the Steroid Treatment As Regular Therapy in early asthma (START) trial"],"prefix":"10.1111","volume":"17","author":[{"given":"Michael","family":"Silverman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Albert L.","family":"Sheffer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia V","family":"D\u00edaz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bengt","family":"Lindberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2006,3,28]]},"reference":[{"key":"e_1_2_5_2_2","first-page":"557","volume-title":"Pulmonary Disorders. 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