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New Inhaled Corticosteroid
JAMA. 2000;284:1640.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA has approved budesonide inhalation suspension (Pulmicort Respules, AstraZeneca Group, Wayne, Pa) as maintenance and prophylactic therapy for asthma in children aged 1 to 8 years. The product, a sterile suspension for inhalation via jet nebulizer, contains the first anti-inflammatory corticosteroid approved for inhalation in children younger than 4 years.
Approval of the micronized budesonide inhalation suspension was based on three double-blind, placebo-controlled, randomized clinical trials of 12 weeks duration. The analysis included 946 patients who were aged 1 to 8 years and had persistent asthma.
The studies showed that when used once or twice per day, up to a total dosage of 1 mg/d, the product significantly decreased asthma symptom scores across sex and age groups and significantly reduced the need for bronchodilator therapy. A reduction of 0.28 to 0.57 on a scale of 0-3 in nighttime and daytime symptom scores of asthma was observed within 2 to . . . [Full Text of this Article]
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