Long Term safety & efficacy of budesonide inhalation suspension in Japanese children with bronchial asthma

Inclusion Criteria

• Inclusion Criteria:
• - 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient’s caregiver wished the continued treatment with budesonide inhalation suspension
• A written consent to participate in this study had been obtained from the patient’s legal representative (a person who exercises parental authority for the patient, or if no one was applicable, a guardian: in principle, the patient’s parent).
• 3. The patient was younger than 5 years old. Patients aged 5 years could be included in this study if no other effective treatment for the patient’s bronchial asthma was available as judged by the investigator(s).
• Exclusion Criteria:
• -1. Concurrent severe diseases of liver, kidney, heart or other complications.
• 2. Contra-indications (eg, known or suspected allergy) to budesonide or excipients contained in the investigational product.
• 3. Other conditions, in which the investigator(s) judges patient’s participation in this study inappropriate.