This study is as an extension study of SD-004-0765, to assess the safety profile of long-term use of budesonide inhalation suspension in Japanese young children with bronchial asthma. Children completing study SD-004-0765 continued administration of budesonide inhalation suspension as judged by the investigator; the dose is adjusted as appropriate within the range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Isehara, Kanagawa, Japan
Unnamed facility
Tsu, Mie-ken, Japan
Unnamed facility
Kurashiki, Okayama-ken, Japan
The safety profile of long-term use of budesonide inhalation suspension assessed by evaluation of frequency and intensity of adverse events, plasma cortisol, physical examination, height, weight and clinical laboratory values.
The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator
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Unnamed facility
Hioshima, Japan
Unnamed facility
Kanagawa, Japan
Unnamed facility
Matsuyama, Japan
Unnamed facility
Obhu-city, Japan
Unnamed facility
Tokyo, Japan